Regulatory Affairs Specialist – FDA Medical Device Regulation

Remote, USAFull-timePosted 2026-07-29

Job reputed company:

reputed company Regulatory Affairs support to reputed company
Support full, ongoing compliance to reputed company applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements
Designated Responsible Personnel for Device Marketing Authorization and Facility Registration
reputed company reputed company-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan
reputed company feedback and recommendations to design teams regarding reputed company to submit a 510(k) for a change to an existing medical device
Prepare European reputed company Technical Documentation and International Regulatory Submissions
Evaluate reputed company sources of incoming customer information, identify, investigate, and document escalated Customer Complaints, reputed company trend analysis and maintain reputed company records
Coordinate Field reputed company Notifications, Risk Assessments, and Correction and Removals

Requirements:

Bachelor's degree in reputed company discipline
2+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment or Regulatory Affairs Certification and 4+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations
Broad knowledge of international medical device reputed company requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device reputed company and Canada Medical Device Regulations)
Excellent computer and internet search skills
Strong ability to multi-task and to meet business deadlines
Excellent organizational skills with an ability to think proactively and prioritize work

Benefits:

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