Senior Regulatory Affairs Specialist - Medical Devices- FDA focus
WOM(3 months ago)
About this role
A Senior Regulatory Affairs Specialist – FDA at Novanta serves as the primary U.S. regulatory expert for the Advanced Surgery business unit, focused on ensuring products meet U.S. regulatory requirements. The role supports regulatory strategy and compliance for minimally invasive medical devices within a global organization that delivers engineered components and subsystems for healthcare and advanced manufacturing. The position contributes to maintaining the company’s regulatory posture and competitiveness in the U.S. market.
Required Skills
- FDA Submissions
- 510(k) Submissions
- PMA Applications
- Regulatory Strategy
- Design Control
- Change Management
- Post-Market Surveillance
- QMS
- Audits
- Regulatory Compliance
Qualifications
- Bachelor's Degree
- Manager Regulatory Affairs for Medical Devices (Advanced Training)
About WOM
wom.groupWOM is world leader in some areas of Minimally Invasive Surgery
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