We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include : Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
Responsibilities
* 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.
* Plan and 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.
Qualifications
* Essential: 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
* Essential: 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).
* Essential: 2+ years experience in team management (must have)
* Essential: 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
* 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
* Has a keen eye for detail and is focussed on delivering results within agreed timeframes
* Operates ethically with the highest degree of professional integrity
More information
* Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
Why SGS?
* 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.
Join Us : At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.
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