JOB DESCRIPTION

• Provide clinical expertise in clinical evaluation, and literature search and appraisal technical documentation according to MDR 2017/745 and MEDDEV guidelines.
• Provide clinical expertise in post-market clinical follow-up (PMCF) and post-market surveillance (PMS) technical documentation including the creation and update of the Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745 and MDCG guidelines.
• Provide safety and clinical assessment of complaints and adverse events including technical write-up of the manufacturer’s incident report (MIR).
• Create, review and update procedures, work instructions, protocols and reports related to clinical evaluation, literature search and appraisal, post-market clinical follow-up (PMCF), post-market surveillance (PMS) and Summary of Safety and Clinical Performance (SSCP) according to current standards and guidance, and periodic schedule.
• Participate in the risk management team and provide safety and clinical assessment in the risk management file (RMF) on identified risks from different data sources during post-production processes that is in accordance with the requirements of ISO 14971.
• Provide support in the MDR documentation, application, submission and review as and when needed by the superior.
• Provide support in the creation, update and maintenance of the technical files according to MDR 2017/745 requirements.
• Perform market research and analysis on clinical trials and product outlook from different online sources.
• Provide support on the internal audits and external certification audits in compliance with ISO 13485, other applicable standards and regulations.
• Plan, develop and implement clinical strategies in accordance with applicable guidance, standards and regulations.
• Interface with Bioptimal’s contracted manufacturer on the clinical needs of the company and the strategies to obtain compliance to applicable guidance, standards and regulations.
• Act as Singapore representative in communicating the clinical needs to different stakeholders and obtaining approval on clinical evaluations.
• Take lead in the creation, update, execution, follow-up and compiling of clinical surveys according to procedure.

REQUIREMENTS

• Degree in medical or in life science with at least 5 years professional work experience in invasive catheter or cardiology related medical devices’ clinical evaluation, with PhD is an added advantage.
• Working knowledge on regulatory requirements relating to clinical evaluation is a must, with MDR 2017/745 background is an added advantage.
• Preferably with good research methodology (including clinical investigation design and biostatistics).
• Must be scientific and data-driven with good information management (experience with relevant databases such as Embase, Medline, PubMed, etc.)
• Fluent and experienced in technical writing related to clinical evaluation and literature search and appraisal.
• Fluent in both verbal and written English.
• With high level of integrity and able to work on tight deadlines and deliver results as per schedules.
• Self-starter, independent, analytical thinker and able to recommend sound, logical advice to management in accordance with applicable regulations and guidance.
• With good interpersonal and communication skills, positive outlook and able to get along with peers.

The Director of Branding will be responsible for developing and executing global brand campaigns promoting Surbana Jurong Group as a diverse collective of problem solvers for the built environment, with a focus on design excellence, sustainability, digital and technology, client-centricity and exceptional employee experience.

Key Responsibilities

• Bring our Purpose to life, infusing "Real Impact, Made Together," into all branding initiatives
• Promote SJ Campus as an icon of the Surbana Jurong Group
• Drive brand campaigns that communicate the breadth and depth of our full-suite solutions in urban planning, infrastructure, and management consulting.
• Develop and implement campaigns that position Surbana Jurong Group as an employer of choice in the built environment industry
• Celebrate our company culture, employee development programmes, and opportunities for professional growth
• Lead the development of SJ Group's brand to drive greater impact and cohesion in the group identity
• Lead the Group’s social media strategy, ensuring engaging, relevant content on LinkedIn and other digital platforms
• Spearhead the refresh of the SJ Group website, enhancing its functionality, design, and content to better reflect its brand and purpose, and serve our audiences.

Measurement

Establish key performance indicators (KPIs) for branding campaigns and analyse results. Use data-driven insights to refine and optimise branding strategies.

About Surbana Jurong Group

Surbana Jurong Group is a diverse collective of problem solvers for the built environment, continually reimagining ways to create a smart and sustainable future.

Headquartered in Singapore, the group has a global talent pool of 16,000 in Surbana Jurong and its member companies AETOS, Atelier Ten, B+H, CHIL, KTP, Prostruct, Robert Bird Group, SAA and SMEC, based in more than 120 offices in over 40 countries. They include architects, designers, planners, engineers, facilities managers and other specialists driven by progressive thinking and creative ideas to shape a better future.

Its technical experts deliver sustainable solutions that cover the entire project life cycle from planning and design, through to delivery and management, as well as a full suite of multidisciplinary consultancy services across a diverse range of sectors including transportation, water, aviation, healthcare, hospitality and renewables.

The Group is #23 in Engineering News-Record’s 2023 Top 225 International Design Firms, #13 in World Architecture 100 2023, and Asia Pacific FM Technology Provider of the Year 2022, awarded by International Facility Management Association.

Our purpose, "Real Impact, Made Together," reflects our collaborative approach to creating meaningful and lasting positive change in the world.