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

We are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity, and the delivery of high-quality assessments aligned with MDR and IVDR.

Your Mission

As Regulatory Manager, you will :

• Serve as the primary contact for regulatory matters, including communication with designating authorities, notified bodies (NB), UK Approved Bodies (UKAB), competent authorities, the Commission, and other external regulatory stakeholders.
• Act as the regulatory ambassador for various Medical Schemes and the main liaison to Team NB.
• 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.
• Support line managers in conducting annual risk analyses to confirm the impartiality and independence of Notified Body staff.
• Plan, organise, and implement relevant regulatory training programs.
• Ensure the SGS Medical website remains current and accurate in terms of regulatory content.

Qualifications

Education :

Experience and skills :

Please kindly 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.

Job Location

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