For The Candidates
Ra / Qa Manager - Regulatory affairs - Medical Device
(216) Area Code Ohio
Regulatory Affairs Manager
- Manage adverse event complaint handling process. Manage Corporate Complaint handling system for all North American facilities in conformance with FDA and Health Canada requirements. Ensure that all potential sources of complaints are reviewed and documented per these requirements.
- Ensure that adverse event complaint information is reviewed on a timely basis for information which may require reporting to FDA under the MDR Reporting Regulation. Determine if MDR reports are required and submit reports when necessary. Ensure that decisions not to file such reports are justified and documented.
- Manage investigation and follow-up activity of safety related product issues where injury or the potential for injury has been identified. Ensure appropriate documentation is included in the complaint files. Review complaint responses for adequacy and close out complaint files accordingly.
- Track progress of recalls and submit monthly updates as required to meet FDA requirements.
- Participate in Safety Committee meetings and provide updates regarding complaint / MDR activity and recall status. Perform trend analysis and ensure complaint information is communicated regularly to all Invacare personnel who need this information.
- Submit 510(k) applications to FDA when requested by supervisor and participate in the engineering change control process to provide guidance regarding engineering changes and potential 510(k) or other regulatory impact.
- Four (4) year Technical Degree or equivalent experience.
- Knowledge and understanding of QSR’s and ISO Quality System Requirements. RAC Certification desirable
- Minimum 5 years Quality Assurance or Regulatory experience in a Manufacturing Discipline.
- Thorough knowledge of trend analysis reporting techniques and methods.
- Previous experience in product failure analysis desirable.
- 3 - years experience with Medical Device Reporting
- Experience with FDA 510(k) submissions and Part 806 requirements
- Excellent oral and written communication skills.
- Some supervisory experience is required.
- Ability/willingness to travel.
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