Designated Responsible Personnel for Device Marketing Authorization and Facility Registration.
Perform Pre-Market U.S. FDA submissions (510(k) and PMA).
Provide feedback and recommendations to design teams.
Prepare European Union Technical Documentation and International Regulatory Submissions.
Evaluate all sources of incoming customer information, identify, investigate, and document escalated Customer Complaints.
Confirm the Medical Device Reportability of identified potential adverse events.
Coordinate Field Action Notifications, Risk Assessments, and Correction and Removals.
Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales.

Bachelor's degree in related discipline and 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 standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations).
Excellent leadership, communication, collaboration, team work and interpersonal skills.
Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
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.

Regulatory Affairs Specialist – FDA Medical Device Regulation

Key skills