Regulatory Manager

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:

• Advanced degree in a clinically relevant field; additional training in medical device clinical evaluation and performance studies would be a strong advantage.

Experience and skills:

• Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR)
• 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 (a must have)
• Negotiation and persuasion skills
• Change Management skills
• Strong organisational skills and flexibility
• 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).
• 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
• Keen eye for detail and is focussed on delivering results within agreed timeframes
• Operates ethically with the highest degree of professional integrity

Please kindly send your CV in English

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.

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.

Originally posted on Himalayas