Job Summary
We are seeking a Quality and Regulatory Manager to centrally manage our Lean and compliant Quality Management system for medical devices schemes.
* This role will report to the Head of Certification and Compliance, Business Assurance.
* The role is remote based, and we are open to candidates located everywhere across Europe.
Main Responsibilities
1. Manage all medical devices processes, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality.
2. Supervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements.
3. Ensure impartiality and independence from commercial interests, including conducting annual risk analyses.
4. Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
5. Lead internal and external audits and ensure timely closure of CAPAs.
6. Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
7. Write and revise QA-related procedures and associated documentation.
8. Continuously optimise the QMS to improve turnaround times while maintaining compliance.
9. Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives.
10. Compile and analyse data for management review reporting.
11. Manage all regulatory processes to ensure full compliance across all Medical Schemes.
12. Ensure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained.
13. Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices.
14. Plan and implement relevant regulatory training programs in collaboration with the training team.
15. Ensure the SGS Medical website remains current and accurate in terms of regulatory content.
16. Build strong working relationships with global medical device teams and proactively work on projects with stakeholders.
17. Provide technical support and training across the business, when required.
18. Manage and develop the Quality & Regulatory team, including performance management, coaching, and staff development.