Related skills
documentation project management regulatory affairs fda 510(k)📋 Description
- Develops and executes regulatory strategies for IVD systems.
- Coordinates EU/IVD submissions, 510(k), NYS DoH, and global registrations.
- Advocates least burdensome approaches to product clearance.
- Represents RA to stakeholders on regulatory path, claims, and labeling.
- Evaluates product changes for impact to global submissions.
- Reviews advertising/promotional materials for regulatory compliance.
🎯 Requirements
- Bachelor's degree in life sciences; advanced degree preferred.
- RAC preferred.
- Minimum 12 years regulatory experience in medical devices.
- IVD experience and CDx a plus; PMA preferred.
- Minimum 5 years managerial experience preferred.
- US/EU Medical Device/IVD regulatory knowledge.
- Self-starter with strong communication and talent development.
- Independent judgment and project management capabilities.
🎁 Benefits
- Comprehensive medical, dental, vision, life and disability coverage.
- Free testing for employees and dependents; fertility care benefits.
- Pregnancy and baby bonding leave.
- 401(k) retirement plan and commuter benefits.
- Employee referral program.
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