Principal Regulatory Affairs Specialist - Mervue
Medtronic(26 days ago)
About this role
The Principal Regulatory Affairs Specialist at Medtronic leads regulatory activities for the DAR Breathing System within the Acute Care & Monitoring unit, working across global teams and regulatory jurisdictions. The role supports the product regulatory lifecycle and helps ensure the organization meets applicable medical device regulatory requirements.
Required Skills
- Regulatory Strategy
- Submissions
- Change Control
- CE-Mark
- FDA
- EU MDR
- 510k
- Technical Writing
- Labeling Review
- GMP Audits
+3 more
Qualifications
- Level 8 Honours Degree in Science or Engineering
- Bachelor's Degree
- Master's Degree
- Regulatory Affairs Qualification (desirable)
About Medtronic
medtronic.comPeople-centered, data-driven, personalized. Solving our world’s biggest health challenges with advanced technology.
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