Director of Regulatory Affairs (Medical Device) - HYBRID in Bay Area
Our esteemed client, a innovative and growing medical device company specializing in the manufacturing of implantable medical devices. They are looking for a Director of Regulatory Affairs with experience to spearhead regulatory strategies for Class II and Class III Cardiology and/or Cardiovascular Devices.
Key Responsibilities:
- Develop and implement global regulatory strategies for the successful approval and commercialization of active/implantable devices in the US and international markets.
- Oversee the preparation and submission of regulatory dossiers for FDA and OUS regulatory approvals, including IDE, 510(k), PMA, and CE Mark applications.
- Act as the primary point of contact with regulatory authorities, ensuring open communication and successful interactions during the review process.
- Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and other departments to align regulatory objectives with business goals.
- Stay abreast of evolving regulatory requirements and industry trends, providing guidance to the executive team and ensuring the company's ongoing compliance with global regulations.
- Experience with active implantable devices and Software experience/Cybersecurity would be a plus.
- Build and develop a proactive, versatile and cross functional regulatory team.
Qualifications:
- A minimum of 8 years of experience in regulatory affairs within the medical device industry.
- Proven track record of successful regulatory submissions and approvals in both the US (510k, De Novo, PMA) and international markets (CE Mark and OUS submissions).
- Strong leadership and management skills, with experience leading regulatory teams and driving results in a fast-paced environment.
- Deep knowledge of the full product lifecycle for Medical Devices.
- In-depth knowledge of global medical device regulations, standards, and guidelines, and the ability to interpret and apply them effectively.
- Excellent communication and interpersonal skills, with the ability to build relationships with regulatory authorities and cross-functional teams.
- A bachelor's degree in a related field (Engineering); an advanced degree is preferred.
If you would like to learn more about this Director of Regulatory Affairs opportunity and have the desire to build and develop a regulatory team, apply today or contact me directly on the following:
wjlynch@barringtonjames.com
