Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable, and easy to use to empower athletes at all skill levels to analyze and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up their game across the world. Trusted by coaches and players from youths to professionals, Rapsodo provides real-time insights for all-time performance.

We are innovative, focused, and rapidly growing. We are continuously looking for very driven team players who will stop at nothing to deliver state-of-the-art solutions as part of Team Rapsodo.

We are seeking an IT Specialist to be part of our global team responsible for managing policies and procedures.

Key Responsibilities:

• Monitoring and configuration of WAN & LAN connections and devices
• Monitoring firewall logs and maintaining backups
• Managing of Microsoft 365 accounts & licenses
• Responsible for all hardware & software assets, IT inventory and licenses
• Troubleshoot, install, repair, and deployment of workstations (desktops/laptops/servers)
• Applying information security procedures and practices to IT infrastructure
• Providing Level 1 and 2 support to global service desk operations
• Deploying and configuring existing and new business processes

Skills & Qualifications:

• Minimum 1-3 years of relevant working experience
• Creative, solution-oriented, open to innovations, constantly following technology
• Sound understanding of network and internet access such as WAN & LAN, TCP/IP, SSL, firewalls and VPNs
• Must have experience with MacOS/iPadOS/iOS devices
• Must have experience with Linux OS devices such as Ubuntu
• Familiar with Microsoft 365 administration
• Experience in setup/configuration of antivirus & anti-spam applications
• Experience with backup process and tools
• Working knowledge of requirements of ISO 27001 & PDPA
• Familiar with business process management & corporate IT procedures

Job Description & Requirements

Responsibilities:

• To prepare and arrange M&E installation in accordance with approved drawings and materials
• To carry out site supervision on M&E works and arrange inspection with RTO
• To supervise subcon's works and progress in accordance to schedule set
• To coordinate M&E works on-site with other trades
• To support Safety team by ensuring subcontractors are complying to safety procedures and requirements
• Liaise and work with relevant authorities/ subcontractors/ clients on shop drawings/ equipment submission, inspections, testing requirements and commissioning

Requirements:

• Experience in M&E Engineering, A&A, ELU works
• Proficient skill in autoCAD preferred
• Must be team player and have the ability to interact effectively with all levels of management

*Please state your earliest commencement date.

Job Description

The main duties and responsibilities of the Emergency Response Team (ERT) member are as follows:

• To respond in time to safely extricate personnel working in the cleanroom in urgent event such as gas leak. ERT must put on protective gears before it is safe to enter the cleanrooms;
• To be able to make critical assessment of the situation to stop the leakage of toxic or flammable gases; and
• To perform safety-related work such as

1. conduct safety training for personnel who needs to work in the cleanroom;
2. carry out periodic emergency response drill to familiarize personnel with standard evacuation and response procedure.

• To be on standby / on-site for ad-hoc / extended hours lab operations request
• To liaise with supplier for maintenance / procurement of ERT equipment / supplies
• Move around and keep a lookout around E6 Labs and cleanrooms for any safety violations/abnormal behaviour/housekeeping/potential hazards etc.
• Any other duties as assigned.

Qualifications

• At least a NITEC or equivalent with relevant working experience.
• Prior emergency response (ERT) experience is preferred.
• Good knowledge of cleanroom operations and toxic gas delivery is preferred.
• Must be willing to perform shift duties. Should a need arises, the incumbent is required to work on Saturdays.
• Good knowledge of Microsoft office; Word, Excel, PowerPoint, Microsoft Teams).
• Good communication and interpersonal skills.
• Good team player and adaptable to a dynamic environment.
• Preferably with safety related certification

Interested applicants are invited to apply directly at the NUS Career Portal.

Your application will be processed only if you apply via NUS Career Portal.

We regret that only shortlisted candidates will be notified.

• Advisory on SG regulations to SG Business Units (Deposits, Loans, Investments, Marketing, and Operations) for new product and system launches, as well as on BAU basis after each launch
• Manage compliance risks and uphold compliance with SG regulations for all functions throughout the bank
• Participate in system configuration discussions and UAT (including reviewing business SOPs)
• Highlight new regulations and regulatory expectations to various business and corporate functions and senior management, and help operationalize, where necessary
• Perform assessments on regulatory escalations and make recommendations for remediation measures
• Conduct Key Obligation Register exercise covering Business and Support Units
• Establish SG-wide assurance guidelines, drawing from higher risk areas based on internal risk reviews and assessments
• Perform assurance testing, identifying any compliance gaps in business processes and workflows, and make recommendations for remediation measures
• Monitor remediation plans for completed compliance tests
• Assist to prepare any relevant materials for training and management reporting purposes

Requirements:

• Bachelor’s degree or higher in Accountancy, Banking or Business equivalent
• 7-12 years of relevant experience in the space of regulatory compliance, including Anti-Money Laundering, consumer/corporate/investment products, operational risk management, technology risk management, and preferably with Banks, Financial Institutions, or reputable consulting firms
• Relevant regulatory compliance experience to support retail products such as unsecured facilities, credit card, personal wealth investment and insurance is a plus
• Good project management and problem-solving abilities with an eye for detail
• Excellent written and verbal communication skills
• Excellent interpretation of laws and regulations
• Able to work effectively with internal and external stakeholders
• Builder mindset, proactive, and a can-do attitude

This role reports to Head, HSSE and QAEP

REQUIREMENTS (QUALIFICATION, EXPERIENCE)

• Bachelor’s Degree in Civil/Mechanical Engineering or Architectural.
• At least 8 years’ experience in managing Quality Assurance for the engineering, procurement and construction especially in infrastructure projects with a minimum of 5 years of managerial experience.
• Responsible for HQ/project quality leadership and management from mobilisation through to completion.
• Require good judgement and the ability to render decisions and/or recommendations where Quality policies and procedures are not clearly defined.
• Familiar with ISO 9001 systems requirements.
• Determined and committed in establishing strong QA/QC processes in CES_SDC projects.
• Passionate in solving problems, team building, up-to-date in QA/QC programs and technologies. Possesses tenacity to commitments and responsibilities.
• Knowledgeable in PQP, ITPs, Method Statements, Inspection Checklists, NCRs, CARs and Root Cause Analysis.

RESPONSIBILITIES FOR HQ

• Establish and maintain effective Quality Management Systems (QMS) for project execution referencing to local requirements, client specifications and CES_SDC requirements.
• Ensure the CES_SDC’s Management System Manual (MSM) and Quality Procedure Manual (QPM) are established and maintained in support of CES_SDC’s Policies, Objectives & Targets, Quality Management Programme, Awards and Certifications
• Work closely with Management Team/HODs/PDs/PMs in meeting CES_SDC’s Quality objectives and targets by initiating, recommending or providing effective corrective actions/risk mitigating control measures through managing changes and documentations in QMS and risk registers.
• Organise and implement Company-wide initiatives and promotional campaigns to elevate Quality awareness and strive towards Quality excellence.
• Evaluate industry best practices for implementation of such practices into the CES_SDC Quality culture.
• Ensure investigations into Non-conformances and CAR are correctly conducted, identifying the root causes and ensuring corrective actions are implemented timely and effectively.
• Consolidate the QA/QC statistics received from each of the CES_SDC Operations, analysing those statistics for trends and recommend corrective actions/mitigating control measures or any necessary improvement plans/opportunities.
• Compile and submit QA/QC report including quarterly statistics to CES_SDC Management, CES Construction Group and client as required.
• Ensuring Quality Alerts and similar communications are distributed across the organisation.
• Provide support and input into tender proposals.
• Manage and ensure effective periodic reviews/internal and external audits/surveillance on Quality Management System.
• Perform other related duties as assigned or indicated by direct supervisor and CES_SDC management.

RESPONSIBILITIES FOR PROJECTS

• Ensure that the CES_SDC’s Quality policy is integrated within Project Quality Management System.
• Ensure that Clients recognise CES_SDC’s commitment to the Quality policies.
• Ensure proper establishment and implementation of Project Quality Plan and Quality Management System.
• Monitor project quality performance and make necessary improvement to the project quality system.
• Evaluate the site personnel’s and vendor’s QA/QC performance and motivate/educate them to perform to the best interest of the project and Company reputation.
• Deploy QA/QC personnel so as to facilitate the effective operation of the project QA/QC department.

Position Summary

This role, QA Automation Engineer or SDET will perform manual and technical testing in coordination with BA and development teams. They will lead QA for projects, features, and coordinate Automation testing execution for a feature or project’s testing. The QA Engineer will also contribute to requirement analysis, test design, and functional requirement verification. Furthermore, they will contribute to API testing, backend testing, data analytics testing, and UI/UX testing, where applicable.

Main Responsibilities

• Take ownership of leading the quality of an assigned project and its features.
• Coordinate the execution of automated tests with a project’s testing cadence.
• Functional/ Regression testing verification.
• Requirement and test analysis.
• Test design and test case review.
• API and backend testing.
• Data analytics testing.
• UI and UX analysis and testing.
• Communicate with stakeholders and teammates of testing status and results.
• Contribute to collaboration with test automation team to continuously expand test coverage.
• Contribute to test case prioritization for manual and automated testing prioritization.
• Contribute to optimizing test case prioritization to increase testing velocity.
• Contribute to Global QA org’s continuous improvement and project team’s quality process.
• Should have worked on Automation Tests for desktop based application.
• Research, design, and develop software.
• Analyse user needs and develop software solutions
• Update software, enhances existing software capabilities, and develops and direct software testing and validation procedures.
• Work with other engineers to integrate hardware and/or software systems
• Develop specifications and performance requirements.

Qualifications and Profile

• Good Knowledge of programming languages like Java, JavaScript and HTML
• Good to have knowledge on Banking or Finance.
• Expertise in automation testing tools like Selenium, Auto IT, Rest Assured , Cypress and Cucumber
• Takes initiative to chase down answers.
• Hands on knowledge of desktop based app and its automation
• Able to adapt to changing business and project priorities.
• Proactive in bringing solutions to observed gaps in requirements and process.
• Proactive in test planning, able to identify and breakout tasks based on a test plan.
• Able to prioritize and execute QA tasks with minimal supervision.
• Execute tasks from QA lead or above.
• Mentor and guide junior level Associate QA Engineers and QA Engineers.
• Perform root cause analysis.
• Install and/or configure tests for systems.
• Optimize test cases for higher efficiency, especially for specific changes in code or features.
• Test client-server interaction.
• Test user behavior analytics.
• Analyze and test UI and UX requirements.
• JIRA and Confluence

Nice to have

• Automation test result analysis and investigation of failures.
• Perform change impact analysis.
• Perform risk-based test analysis.
• Bonus skills and tools knowledge:
• GitHub and Bitbucket
• Docker
• Postman
• Jenkins CI
• Node.js & Selenium WebDriverIO
• JavaScript
• Kubernetes
• Xray test case management tools

Education Requirements

At least a Bachelor’s degree in any of these faculties:

• Computer Science
• Information Technology
• Programming & Systems Analysis
• Science (Computer Studies)

Interested applicants, please email your resume to Shaun Quek Yew Meng

Email: [email protected]

CEI Reg No: R1660732

EA Licence No: 99C4599

Driven by the passion to improve the quality of people’s lives, WS Audiology continues to grow as the market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation to reach more people, more effectively.

Join our Business Quality team as a QMS Specialist based in our Singapore office at Tai Seng. You will play a crucial role in ensuring medical device regulatory compliance for products released to the market and oversee Singapore quality management system maintenance and continuous improvement initiatives.

What you will do

• Document controlImplement and coordinate local Document Control according to internal and legal requirements, such as ISO 13485.
  Ensure adherence to global documents while minimizing local documents, ensuring they align with global standards.
  Participate in and moderate local change board meetings.
  Train and consult team members on Good Documentation Practices (GDP) and process requirements.
  Conduct local meetings to inform stakeholders about document revisions or new releases.
  Maintain a local overview of Quality Management System (QMS) documents, including archiving and revision control.
  Track QMS Change Requests and perform reviews and approvals of revisions or new documents.
  
• Quality Improvement TeamCoordinate and support local Quality Improvement Teams (QIT), acting as the QIT leader.
  Document and archive input from Quality Improvement Team Meetings.
  Follow up on action items resulting from Quality Improvement Team Meetings.
  
• Quality Representative (QS)Prepare and coordinate local Management reviews.
  Act as a Quality Management (QM) Auditor, conducting internal audits.
  Establish, consult, and train management and employees on the Quality System.
  
• Local Training OfficerImplement the training concept locally based on global requirements, additional regulatory requirements, and ISO 13485 standards.
  Train administrators on the training tool.
  Maintain data alongside administrators and update the training matrix in case of revisions.
  Track training status, monitor Key Performance Indicators (KPIs), and perform data analysis.
  Archive quality-relevant training records as needed.
  
• Local Audit ManagementServe as the main contact person for all internal and external Quality Management System (QMS) audits in Singapore.
  Coordinate, prepare, and follow up on audits, aligning plans and agendas with auditees and auditors.
  Coordinate logistical aspects, including organizing facilities and following up on audit findings and improvements.
  
• Ad HocSupport APAC countries on Doc. Control, Training, Product Registration
  

What you bring

• 3 years of relevant experience in QMS within the Medical Device Industry
• Eagerness and willingness to learn, demonstrating a proactive approach to professional development.
• Team Player and ability to perform effectively under pressure delivering high-quality results even in challenging situations.
• Internal Auditor Qualification

Who we are

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

About the Role:

This position has responsibilities for the deployment and standardization of key Quality Assurance (QA) activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in practical adherence to regulatory requirements and applicable standards relevant to the medical business, and always act with focus on quality objectives within the organization.

Roles and responsibilities:

· Ensure correct implementation and maintenance of Quality Systems throughout the organization, with continuous process improvement in adherence to regulatory requirements.

· Develop/update procedures and SOPs for quality systems processes to ensure alignment with Olympus global procedures as well as coordinate with other departments that effect Quality Systems.

· Provide training and support to employees concerning quality systems, policies, procedures, and core processes etc.

· Support audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.

· Manage complaint handling process according to global requirements and regulations.

· Execute recall / field corrective actions and other post-market surveillance within impacted countries in the region.

· Participate in handling of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization’s sites.

· Communicate appropriate quality standards to relevant stakeholders in driving overall site performance and help building culture of quality and continuous improvement.

· Assist administration of management review process, including maintaining compliance to quality system data metrics analysis, monitor and trend quality indicators to proactively report or escalate issues to QARA Manager.

· Support global and local quality improvement initiatives and transformation projects.

· Execute other tasks and projects, as assigned by QARA Manager.

About Olympus:

Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that make a positive contribution to society.

Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental in furthering research, and for travelling inside the human body to help diagnose, treat and prevent illness.

Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?

At Olympus, we are dedicated to fostering a high-performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Integrity, Empathy, Long-Term View, Agility and Unity form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.

Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:

• A competitive salary package including AWS and Variable Bonus
• Hybrid home office work arrangements
• 18 days of annual leave in your first year
• Health and Wellbeing initiatives (Annual Medical Checkups, Flu Vaccinations, Dental benefits, and Employee Assistance Programs)

What we are looking for:

• Bachelor’s Degree in related field of engineering, science, or equivalent experience.
• Prior experience working with quality management system and quality assurance / regulatory compliance
• Demonstrate knowledge to perform internal quality audit
• Minimum 3 years of relevant experience in medical device field
• Good knowledge of quality system regulations and medical device regulatory framework
• Meticulous and strong attention to details
• Excellent verbal and written communication skills
• Good problem solving and influencing skills
• Ability to manage multiple activities in a fast-paced environment with speed and accuracy
• Positive attitude and able to work well as team player

Apply Now:

To submit your interest in this opportunity, select “Apply for this job”.

In the meantime, follow us on:

• LinkedIn - Olympus APAC
• Company website -www.olympus.com.sg

As an Area Sales Specialist for Electrification business, you will be responsible for the sales of products/systems/services within a designated market/division, in line with the division strategy.

Reporting to Sales Manager, you will be achieving both qualitative and quantitative sales targets to ensure sustainable order growth, revenues, profitability, market share, and customer satisfaction.

Responsibilities:

• Selling products/systems/services to customers, focusing on volume, mix, and profitability targets for the assigned divisions.
• Establishing and maintaining effective customer relationships to understand their needs, promotes their understanding of ABB’s complete product/systems/ services offering, and aligns with them to provide a solution.
• Ensuring a positive customer experience throughout the sales process.
• Preparing sales plans using ABB authorized tools. Performing regular status reviews and proposes recovery plan(s), in case of any potential order shortfalls.
• Creating added value for the customer and ABB and ensuring the successful outcome of transactions, contracts, and proposals, by using effective sales techniques.
• Communicating to the customers about the details related to delivery time, payments, and general terms and conditions, in line with ABB’s offering and strategy.
• Ensuring efficient marketing activities and communicates value proposition to customers.
• Identifying and driving the development of new market opportunities in the designated market.

Requirements:

• Degree in Electrical Engineering with ideally some years of Sales experience
• A Self-starter
• Knowledge in cable protection/management products and Earthing & Lightning protection systems
• Knowledge in Medium Voltage (MV) applications and products is an added advantage
• Willing to travel 50%

Job Description & Requirements

Responsiblities

• Accept deliveries and checking the quality of materials against DO
• Inspect all materials received and initiate actions in accordance with company operations, project QA/QC and ISO procedures when non-conformances are identified
• Maintain records of all material control and inspection records in accordance with company procedures
• Identify what critical consumable spares are required and establish a minimum/maximum inventory amount for all materials and consumables in accordance with project requirements
• Inspect and Monitor materials on site (e.g. Dent, Rust, Dust, etc.)
• Conduct training for material handling to prevent damaging of materials
• Monitor materials use on site to meet the schedule according to the plan
• Be the key liaison between site personnel, procurement department, buyers, user departments and suppliers
• Coordinate with company QA/QC department and with client for updating material control management
• Visual Inspection of those tool(s) before scheduling for site use
• Direct and supervise material control workers

Requirements

• Diploma in Engineering
• At least 2 year(s) of working experience in the related field is required for this position
• Specialize in Purchasing/Inventory/Material & Warehouse Management or equivalent
• Possess significant technical knowledge acquired in the EPC industry and capable of effectively managing all technical material need
• Able to work with tight deadlines and process a high volume of work
• Proficient with MS Office (MS Excel and MS Power Point in particular)
• Preferably with WSH-SCW certification

Job Description:

Internal Processes and Reporting

1. Establish and maintain Quality Management System in both local and SEA region.
2. Develop or update procedures and SOPs for quality system process to ensure continuous process improvement is met.
3. Support audit readiness, conduct and prepare for regulatory or external audit as well as internal quality audits to ensure timely execution according to defined schedules.
4. Execute recall or field corrective actions and other post-market surveillance activities within impacted countries in the SEA region.
5. Participate in handling non-conformity, corrective and preventive actions, documentations, supplier quality across the organization’s sites.
6. Assist administration of management review process, including maintaining compliance to quality system data metric analysis, monitor and trend quality indicators to proactively report or escalate issues to QRA manager.
7. Track and monitor both Singapore and Regional KPIs including QA performance and develop monthly and/or quarterly analysis and reports for reporting to Management.
8. Execute other tasks and projects, as assigned by QRA manager.

Project Support, Training and Continuous Improvement

1. Provide QA support to new business development projects for potential or new onboarding customers.
2. Conduct training (both internal and refresher training) on standards and procedure, quality related programs and quality management procedure.
3. Conduct process mapping and identify areas of improvement and implement steps required to improve processes within QA and other functions.
4. Responsible for planning and implementation of QA related projects.

Minimum Qualifications:

• Degree holder in Life science, biomedical engineering-related field or equivalent experience.
• Strong attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
• Able to converse in proficient Chinese.
• Problem-solving mindset and the ability to drive continuous improvement.
• Familiar with GDP and GDPMDS is a plus.
• Familiar with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
• Having quality assurance experience is a plus.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

This role will advance Regulatory Affairs (RA) functions by planning and driving initiatives focused on continuous improvements and operational excellence of regulatory systems and processes, as well as creating and maintaining mechanisms for rapid tactical execution of regulatory tasks. With a strong focus on Regulatory Information Management and Analysis, playing a key role in aligning processes and facilitating the effective execution of regulatory related activities; helping to ensure the right level of cross-functional transparency and accountability through the regulatory process.

• Supporting, and at times, driving the initiative for the effective implementation of a Global Regulatory Information Management System (RIMS) within APAC to facilitate the centralisation of common documentation in support of global registration activities and processes.
• Supporting business needs by liaising with internal partners, Regulatory team, IT, and vendors to identify technical solutions and for translating RA processes into executable workflows
• Maintaining traceability from RA information through the decision-making process into materialised outputs
• Anticipating regulatory or related obstacles and emerging issues throughout the product lifecycle, leveraging and developing a mechanism for regular review and associated actions
• In accordance with evolving regulatory requirements and trends, participating, and at times, driving system and process improvement projects, including but not limited to new regulatory policies, processes and SOPs, ensuring appropriate collaboration with stakeholders.

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline.
• Training in technical operational aspects of Regulatory Affairs, with at least 3 years of direct Regulatory Affairs experience within a medical device company preferably with Orthopaedics
• Able to work independently as well as part of a cross-functional team, with exceptional written and oral communication skills and the ability to successfully build effective working relationship.
• Regulatory Affairs Certification (RAC) an added bonus
• Ability to read and comprehend scientific literature to collect data, establish facts, draw valid conclusions and produce scientifically supported documentation.
• Experience with MS Office as well as SAP

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

Job Description:

1. Review, assess and process safety data and information on timely and accurate manner received from various sources and distribute reports/ dates internally and for regulatory agencies in local and regional setting.
2. Determine initial / follow up status of incoming events.
3. Assist in the preparation of pharmacovigilance documentation for regulatory submission, including periodic safety reports and risk management plans.
4. Perform Pharmacovigilance activities as per product categories requirements including but not limited to, collecting and tracking incoming AE / endpoint information.
5. Assist in the preparation of medical information materials and providing support for medical inquiries.
6. Participate in the development and delivery of pharmacovigilance training programs for internal staff and external stakeholders.
7. Work closely with Medical Scientific Affairs department to perform and follow up causality assessments for reported adverse event (AE).

Minimum Qualifications:

• Degree holder in Pharmacy, Life science or equivalent experience.
• Familarity with coding dictionaries (MedDRA) is a plus.
• Strong attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
• Able to converse in proficient Chinese.
• Strong verbal / written communication skills.
• Able to follow instruction/ guidelines, utilise initiative and work independently.
• Experience in case processing, safety reporting and risk management activities.
• Able to multitask, manage competing priorities and deadlines in fast paced environment.

• 30% resource for global ITC activity as APAC focal points contact
• Work with external advisors to classify the export control numbers (ECCN’s, Control list numbers etc) for all products in line with US, EU, China and other trade regulations
• Manage the integrity of trade data in Asia Pacific Region;
• Identify and analyze global trends and requirements regarding compliance functions, programs, and risk management, develop metrics and indicators
• Drive scalable business solutions with Veolia Engineering, Commercial, Manufacturing, Operations, Logistics, Tax and other business teams to ensure compliance with Global Trade Regulations
• Assist Business Development, Contracts and Operations in identifying export related requirements in new business transactions
• Work with manufactures/vendors/taggers to set up the effective import / export processes to support operations
• Support Export Control Classification Number (ECCN) classifications for international shipments on a regular basis
• Develop framework for enhanced classification program utilized globally for determination of proper classification of materials and accurate payment of duties and taxes applicable

Requirements:

• Strong technical skills and experience with ECCN and HTS classification determination
• In-depth knowledge on import/export regulations and activities
• Prior experience with developing and implementing International Trade Compliance programs in MNC
• Experience with encryption technology and application to export controls preferred
• B.S or equivalent degree - Highly preferred
• Experience working with a Global Trade System such as SAP GTS preferred
• At least 3-5 years of Global Trade related experience preferred
• Experience with global trusted trader programs such as AEO, CSA, NEEC or other similar programs a plus
• Must be able to work with multiple cross functional and cross geographical teams

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
• Prioritising and organising multiples projects with competing priorities
• Participating in regulatory affairs planning for SEA markets
• Providing support in APAC level projects as and when needed
• Regularly maintaining and updating product registration and listing databases for the assigned country
• Implementing change control for already-approved products including regulatory submissions
• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
• Providing input to change management projects for global regulatory change assessments
• Participating and providing support in cross-functional collaboration on new product and country launches
• Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
• Participating in both internal and external quality system audits

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline
• Minimum 4-5 years direct RA experience within a medical device company
• Strong working knowledge of SEA medical device regulations and standards
• Knowledge of global regulations will be advantageous
• Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
• Ability to work in fast paced environment and handle multiple tasks and requests
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
• Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.