Quality & Regulatory Manager

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.

Job Description

Main Purpose of Role

• 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

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

Skills & Knowledge

Essential

Qualifications

Essential

Please send your CV in English

Additional Information

Why SGS?

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.