Director of Regulatory Affairs Medical Devices
Permanent / Germany
Director of Regulatory Affairs Medical Devices Germany
Recruiting for Director of Regulatory Affairs medical devices for our client a leading medical device company with offices globally. The company designs, develops and manufactures its own products for the global market.
- Prepare international and domestic filings/registrations to established timelines and company objectives
- Represent RA department on assigned projects and provide regulatory guidance as appropriate
- Coordinate with international contacts on product changes and regulatory notification / approval requirements
- Prepare reports to meet international regulations and reporting requirements
- Review and approve product design control documentation
- Work with Quality and Engineering in generating risk analysis, FMEA, and FTA reports
- Review and approve document change orders and prepare letters-to-file
- Update departmental procedures as required
- Ensure applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
- Maintain up-to-date knowledge on international and domestic regulatory requirements
- Provide support for implementing and maintaining the effectiveness of the quality system
- Support international product registrations and regulatory approvals
- Ensuring that subcontractors meet regulatory compliance requirements and are approved by regulatory affairs at the initiation stage.
- To liaise closely with the Quality Assurance department
- To liaise closely with the complaint handling team
- To participate in and support activities associated with Pall objectives
- Good oral and written communication with operational management
- Extensive knowledge of FDA Medical Device Regulations ( 21 CFR 801, 820 ff) and Guidelines
- Ability to facilitate and provide leadership when interpreting regulatory standards and guidances
- Good communication with customers, regulatory authorities and approval bodies in Europe
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
- Bachelor's Degree in scientific disipline or equivalent.
- One year plus of Management experience, (remote management experience preferred).
- Minimum 10 years' experience in Regulatory Affairs
- Experience with US Class II Medical Devices.
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email
We regard all communication and correspondence as confidential. Full job descriptions are available on request.