Overview In this Regulatory Affairs role, you will drive regulatory submissions and agency interactions for complex Class III implants. You will collaborate with internal and external partners to assemble and file submissions, respond to information requests, and manage change control in line with FDA requirements. The position involves planning meetings, preparing pre-meeting materials, and ensuring regulatory compliance across programs. You will help shape approval strategies and ensure timely regulatory decisions in a matrix-enabled environment.
Responsibilities- Prepare regulatory submissions (new applications, amendments, renewals, annual reports, variations)
- Analyze regulatory information to inform decisions and seek expert advice as needed
- Coordinate and manage agency meetings and pre-meeting submissions
- Oversee product change control with regulatory policies and company procedures
- Handle government interactions and filing for regulatory approvals
- Author and submit PMA supplements (30-day notices, Real-Time Reviews, 180-Day Supplements, Annual Reports)
- Review/approve engineering and validation study protocols/reports
- Review and approve manufacturing changes for Class III implantable medical devices
- Possibly lead and direct others; operate with creativity and latitude
Key requirements- 6 years pharmaceutical or industry experience
- 3-5 years in quality systems or cross-functional project management
- preferred 6 years pharma experience including 5 in regulatory affairs or 5 in Discovery/ R&D/ Manufacturing
- experience in a complex and matrix environment
- strong oral and written communication skills
- experience working with internal and external partners to deliver products to patients
- knowledge of FDA PMA guidance documents and CFR regulations
- recent experience with Class III implantable medical devices
- strong communication
- ability to work with cross-functional teams
- problem-solving and strategic thinking
- Regulatory submissions and strategy
- PMA submissions (FDA)
- FDA PMA guidance documents and CFR regulations
