Quality & Regulatory Manager

• 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)
• Management of external audits and communication with competent authority
• Management of internal audits and communication with relevant departments
• Maintaining designation under MDR/IVDR and support the development and designation under new schemes
• Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes
• Coordinate all activities with auditing organisations ( Belgian and English competent authority, UKAS, ….)
• Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers.

• 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.
• Supervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements.
• Ensure impartiality and independence from commercial interests, including conducting annual risk analyses.
• Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
• Lead internal and external audits and ensure timely closure of CAPAs.
• Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
• Write and revise QA-related procedures and associated documentation.
• Continuously optimise the QMS to improve turnaround times while maintaining compliance.
• Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives.
• Compile and analyse data for management review reporting.
• Manage all regulatory processes to ensure full compliance across all Medical Schemes.
• Ensure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained.
• 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.
• Planand implement relevant regulatory training programs in collaboration with training team .
• Ensure the SGS Medical website remains current and accurate in terms of regulatory content.
• Build strong working relationships with global medical device teams and proactively work on projects with stakeholders
• Provide technical support and training across the business, when required
• Manage and develop the Quality & regulatory team, including performance management, coaching, and staff development.

• Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP
• Strong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level
• Ability to represent SGS to medical device regulatory authorities and other external fora
• Excellent interpersonal and communication skills including fluency in English
• Negotiation and persuasion skills
• Change Management skills
• Strong organisational skills and flexibilty
• 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).
• 2+ year experience in team management (must have)
• 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
• Has a keen eye for detail and is focussed on delivering results within agreed timeframes
• Operates ethically with the highest degree of professional integrity

• Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
• Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485

• Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuos learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

SGS