Vice President Regulatory Affairs
Found in: Jooble US O C2 - 2 weeks ago
Vice President Regulatory Affairs (Medical Device) - ONSITE in Bay Area
Our esteemed client, a inovative and growing medical device company specializing in the manufacturing of implantable medical devices. They are looking for a Vice President Regulatory Affairs to spearhead regulatory strategies that will shape the future of healthcare and continue building out their Regulatory Department.
Key Responsibilities:
- Develop and implement global regulatory strategies for the successful approval and commercialization of 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 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 12 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 Vice President 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
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