Related skills
iso 13485 mdsap fda 510(k) samd de novo📋 Description
- Lead end-to-end regulatory strategy from concept to commercialization.
- Lead regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA).
- Act as regulatory lead; manage authority interactions and submissions.
- Embed regulatory requirements into product development with cross-functional teams.
- Build and mentor a high-performing regulatory team; optimize workflows.
- Drive proactive regulatory intelligence on EU MDR, AI, FDA guidance.
🎯 Requirements
- Bachelor's in STEM; advanced degree preferred.
- 10+ years in regulatory affairs for Class II devices/SaMD.
- Expertise: FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP.
- Track record managing authority interactions and inspections.
- Proficiency with regulatory info mgmt systems (eSTAR, EUDAMED).
- Strong communication; influence executives.
🎁 Benefits
- Impact health outcomes globally.
- Generous paid time off.
- Stock incentive plans.
- Medical/Dental/Vision, Disability + Life Insurance.
- One Medical membership.
- Parental Leave.
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