Vice President Regulatory Affairs

vor 3 Wochen

Hamburg, Deutschland CM Medical Recruitment Vollzeit

CM Medical is partnered with an exciting start-up in the structural heart device space.

We are seeking an experienced and strategic Head of Regulatory Affairs to lead and oversee the regulatory strategy and execution for their innovative of structural heart device.


Key Responsibilities


  • Lead the development and implementation of global regulatory strategies to ensure timely approvals and market access
  • Oversee the preparation, submission, and maintenance of regulatory filings including IDEs, PMAs, 510(k)s, CE Mark applications, and Technical Files.
  • Ensure compliance with all applicable regulations and standards (FDA, EMA, MDR, etc.) across the product lifecycle.
  • Act as the primary point of contact with U.S. and European regulatory authorities, including the FDA, EMA, and notified bodies.
  • Lead interactions with regulatory agencies, including meetings, communications, and negotiations to ensure favourable outcomes for the company’s products
  • Collaborate closely with the Clinical, Quality, and R&D teams to ensure alignment on regulatory strategy and execution.


Qualifications:


  • Advanced degree in Life Sciences, Engineering, or a related field; a background in regulatory affairs, clinical research, or quality management is highly desirable.
  • Minimum of 15 years of experience in regulatory affairs within the medical device industry, with a significant focus on structural heart devices.
  • In-depth knowledge of FDA, EMA, and EU MDR regulations, particularly related to Class III medical devices.
  • Experience with TAVR, TMVR or TTVR is a big plus


To be considered for this position, please apply directly or email adam.love@medical-cm.com with your resume and availability for a call.


Please note; I anticipate a lot of applicants and I'm simply unable to respond to all. If you do not meet the above criteria and haven't heard from me within 14 days of applying, please assume you have been unsuccessful.

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