Regulatory Affairs Manager

12 hours ago

Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

**Job description**

To advance and achieve member policy objectives on key regulatory issues of concern to manufacturers of medical technology in Asia Pacific. To provide substantial expertise, assistance and representation on regulatory issues related to medical devices, equipment and IVD in Asia Pacific. The position reports to the Director - Regulatory Affairs.
- Represents APACMed’s positions and fosters and maintains key relationships/partnerships with regulators and other stakeholders to leverage/support APACMed priorities (e.g. regulatory convergence and capacity building). Such stakeholders may include WHO, GHWP, AMDC, APEC-RHSC and IMDRF.
- Strategizes, advises and supports the RA Committee to develop consensus policy to promote medical device industry priorities, including directing regulatory policy development.
- Drafting of policy recommendations, position papers, press releases, OpEd’s/articles, speeches etc for advocacy and thought leadership.
- Develop in-house papers/concept notes through primary and secondary research
- Run monthly meetings of the CoE’s and Working groups to selecting, discussing and reviewing issues, establishing priorities, and implementing programs; provides regulatory assistance and guidance.
- Keep abreast of industry/regulatory trends and monitors regulatory and policy developments and activities across major Asia Pacific markets and works with the RA Committee to coordinate communications to members.
- Supports and leads workshops, educational and roundtable programs, Conferences and Seminars (including conceptualization of program, finalizing background papers, topics for discussion, talking points, identifying target participants, speakers, sponsors, event marketing, logistics etc.
- Supports the creation of new resource materials and updates for APACMed, including RA newsletter.
- Represents APACMed’s positions to regulatory bodies, government agencies, standards organizations, industry professionals, academics and other groups.
- Supports RA Director in driving key regional projects and initiatives
- Works closely with senior member company executives that lead the Functional Committees of the Association.

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