Senior Regulatory Affairs Specialist
Integer(4 months ago)
About this role
This role leads regulatory affairs activities to secure and maintain medical device approvals in the U.S. and international markets while ensuring ongoing compliance with key regulatory standards. The position partners closely with product development and cross-functional stakeholders to support successful commercialization and post-market regulatory status.
Required Skills
- Regulatory Strategy
- FDA Submissions
- International Submissions
- Medical Device Regulation
- ISO Compliance
- Quality System Regulation
- Technical Writing
- Post-Market Surveillance
- MDR Reporting
- Change Control
+5 more
Qualifications
- Bachelor’s Degree
About Integer
integer.netIt seems I am unable to access the content of the website. However, if you provide me with some details about the company or its products/services, I can create a company profile based on that information. Alternatively, I can generate a general profile based on what I know about the company if you provide its name.
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