Job Description
Main Purpose of Role
1. To centrally manage a Lean and compliant Quality Management system for medical devices schemes (Medical includes Notified Body NB1639, UKCA, ISO 13485, MDSAP and all other Medical Schemes at SGS)
2. Management of external audits and communication with competent authority
3. Management of internal audits and communication with relevant departments
4. Maintaining designation under MDR/IVDR and support the development and designation under new schemes
5. Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes
6. Coordinate all activities with auditing organisations ( Belgian and English competent authority, UKAS, ….)
7. Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers
This role will report to the Head of Certification and Compliance, Business Assurance.
It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.
Key Accountabilities
8. Own and oversee 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.
9. Supervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements.
10. Ensure impartiality and independence from commercial interests, including conducting annual risk analyses.
11. Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
12. Lead internal and external audits and ensure timely closure of CAPAs.
13. Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
14. Write and revise QA-related procedures and associated documentation.
15. Continuously optimise the QMS to improve turnaround times while maintaining compliance.
16. Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives.
17. Compile and analyse data for management review reporting.
18. Manage all regulatory processes to ensure full compliance across all Medical Schemes.
19. Ensure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained.
20. 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.
21. Planand implement relevant regulatory training programs in collaboration with training team .
22. Ensure the SGS Medical website remains current and accurate in terms of regulatory content.
23. Build strong working relationships with global medical device teams and proactively work on projects with stakeholders
24. Provide technical support and training across the business, when required
25. Manage and develop the Quality & regulatory team, including performance management, coaching, and staff development.
Skills & Knowledge
Essential
26. Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP
27. Strong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level
28. Ability to represent SGS to medical device regulatory authorities and other external fora
29. Excellent interpersonal and communication skills including fluency in English
30. Negotiation and persuasion skills
31. Change Management skills
32. Strong organisational skills and flexibilty
33. 5+ years’ experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have).
34. 2+ year experience in team management (must have)
35. Has at least 10 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry
36. Has a keen eye for detail and is focussed on delivering results within agreed timeframes
37. Operates ethically with the highest degree of professional integrity
Qualifications
Qualifications
Essential
38. Higher education qualification (Masters / / (Hons) Degree) in a relevant life / natural sciences subject.
39. Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485
Please send your CV in English