Strategic Regulatory Affairs Leader
Vor 5 Tagen
CM Medical Recruitment is seeking an experienced and strategic Regulatory Affairs professional to lead and oversee the regulatory strategy and execution for a start-up in the structural heart device space.
Key Responsibilities:
- Develop and implement global regulatory strategies to ensure timely approvals and market access for innovative structural heart devices.
- Oversee the preparation, submission, and maintenance of regulatory filings, including IDEs, PMAs, 510(k)s, CE Mark applications, and Technical Files.
- Ensure compliance with FDA, EMA, and EU MDR regulations across the product lifecycle.
- Act as the primary point of contact with regulatory authorities, including the FDA, EMA, and notified bodies.
- Lead interactions with regulatory agencies, including meetings, communications, and negotiations to ensure favorable outcomes for the company's products.
- Collaborate closely with 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 significant advantage.
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