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.
