Regulatory Affairs Specialist – FDA Medical Device Regulation

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: • Health insurance • 401(k) matching • Flexible work hours • reputed company time off Apply tot his job Apply To this Job Apply tot his job Apply To this Job