Quality and Regulatory Affairs Manager
Do you have experience using medical devices within an R&D environment?
Are you familiar with Regulatory standards including CE Mark and FDA 510K?
Have you previously facilitated annual clinical reviews?
MacGregor Black are partnering with a Research and Development Consumer Company on the search for a Quality and Regulatory Affairs Manager. This is a permanent role based in Glasgow.
As the Quality and Regulatory Affairs Manager you will co-ordinate the day to day management of the Quality Management System and Regulatory Affairs
- Manage the implementation and maintenance of the Quality Management System to ISO 13485, ISO 9001 and CFR 820
- Process development and improvement
- Delegate Authority on QMS Documentation sign off representing CEO
- Coordinate CCA / CAPA process, update CAPA log with NC data
- Tracking and updates to training matrix / records
- Develop and maintain material safety records and write appropriate risk assessments
- Build relationships with suppliers and help develop incoming material quality standards
- Manage the registration and maintenance of regulatory issues including initial registration in Europe (CE Mark), USA (FDA 510K), appropriate regulatory submissions in SE Asia and other areas globally
- Build and Compliance review of established and new Technical Files
- Facilitate Annual Clinical Review
- Maintenance of regulatory updates in the design and manufacturing processes
- Coordinate Management Review Meetings
- Prepare Audit Plans
- In role of Internal Auditor, conduct audits of internal operations in accordance with planned arrangements
- Compile and report on audit findings NCR/OFIs to CEO
- Contact auditee to establish implementation of solution(s) and verification of closure
- Liaison with Notified Bodies for all visits and regulatory affairs
What we are looking for:
- Experience with medical devices
- Ideally from a Research & Development or Manufacturing background
Salary on offer is up to £35k + Benefits.
Please contact Craig Grainger today for further information.