Senior Regulatory Affairs Leader
1 week ago
Join a prominent global life sciences organization specializing in medical devices, where you will engage with intricate devices and navigate complex regulatory frameworks. This role primarily focuses on managing PMA supplements and new 510(k) submissions, offering you the opportunity to enhance your project management capabilities.
This full-time position allows for 80% remote work, while requiring proximity to the office for essential audits, submissions, and collaborative meetings.
Key Responsibilities
- Oversee, prepare, and execute regulatory submissions for the FDA, including Premarket Notification 510(k), Pre-Submissions, Investigational Device Exemptions (IDE), and Premarket Approval (PMA) submissions, ensuring timely completion. Serve as the primary contact with the FDA regarding product submissions.
- Provide leadership within regulatory affairs and contribute to advanced product development teams by interpreting regulatory requirements and offering valuable mentorship throughout the product development process leading up to regulatory submission.
Qualifications
- A minimum of 7 years of experience in Regulatory Affairs within the Life Sciences sector, with a background in complex devices (PMA, De Novo, or BLA submissions) is essential.
- Exceptional technical writing abilities are required; candidates will need to present a writing sample during the interview process.
- A Bachelor's degree in engineering or a life sciences field is mandatory.
- Candidates must reside within a two-hour driving radius of the office and be willing to attend on-site meetings as necessary.
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