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Lead Regulatory Compliance Specialist
2 months ago
Join a prominent global life sciences organization within their medical devices sector, focusing on intricate devices and regulatory pathways. This role offers the opportunity to enhance your project management capabilities while primarily handling PMA supplements and new 510(k) submissions.
This position is a full-time role that allows for 80% remote work, though it necessitates proximity to the office for audits, submissions, and various meetings.
Key Responsibilities
- Oversee, prepare, and execute regulatory documentation for the FDA, including Premarket Notification 510(k), Pre-Submissions, Investigational Device Exemptions (IDE), and Premarket Approval (PMA) submissions promptly. Serve as the primary contact with the FDA regarding product submissions.
- Lead regulatory affairs initiatives and exhibit leadership within advanced product development teams by interpreting requirements and providing 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, particularly with complex devices (PMA, De Novo, or BLA submissions).
- Exceptional technical writing abilities; a writing sample will be requested during the interview process.
- A Bachelor's degree in an engineering or life sciences field.
- Must reside within a two-hour driving radius of the office and be willing to attend on-site when necessary.
