Regulatory Affairs, Medical Device Pipeline
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Regulatory Affairs, Medical Device Pipeline
Ref No.: 18-00421
Location: Cambridge, Massachusetts
Start Date: 02/07/2018

Description:
The incumbent will be primarily focused on client's Digital Health and drug delivery device systems technology. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to new guidelines.

Responsibilities:
  • Develop innovative and sustainable medical device regulatory strategies covering: digital health device technology and drug delivery device systems (device elements);
  • In conjunction with other groups, develop positions for the client medtech and device development portfolio, both in early and late development;
  • Engage with the relevant regulatory bodies and industry groups to ensure that client's best interests are represented;
  • Work closely with external manufacturing partners to make sure regulatory issues are addressed properly and according to client standards.
  • The critical and highly visible position offers the successful candidate to be at the forefront of client's exciting development pipeline and also covers a wide range of products from software-based programs through to drug delivery devices.

Requirements:
  • At least 10 years' in the global healthcare industry with extensive regulatory experience (10+years) in medical devices – drug combinations;
  • Thorough understanding of and experience with global medical device regulatory approvals;
  • Prior experience in dealing with regulatory authorities;
  • Proven ability to work cross-functionally in a highly professional global environment.
  • Life Sciences degree