Manager - Regulatory Affairs & Quality Assurance Medical Device

24.06. | Executive po­si­tion | 100%

Manage quality and ensure that requirements and standards are met. Obtain and maintain authorisation to market medical devices in countries world-wide.

Manager - Regulatory Affairs & Quality Assurance Medical Device

International small sized company.


  • Oversee the department's management and promotion of the Quality System; care for its on-going improvement.
  • Report to Management Representative on the performance of the quality management system and any need for improvement.
  • Ensure that the company's Quality Policy and set objectives are met; plan and implement monitoring, measurement, analysis and improvement of quality performances of the organisation.
  • Set up quality strategy, quality objectives & guidelines (e.g. Critical Control Points, Lowest and Highest Acceptance Levels).
  • Implement requirements, both internally and towards external partners and suppliers.
  • Take part in the design and realisation/industrialisation of the products (choice of technical means, quality strategy, process monitoring, etc.)
  • Manage internal and external audits.
  • Ensure that nonconformities and vigilance cases (complaints/vigilance events, withdrawals, recalls etc.) are handled promptly and correctly.

  • Handle submission/registration activities for the product portfolio in Europe and international markets.
  • Support distributors to ensure the regulatory compliance of our products with national regulations.
  • Determine submission and approval requirements.
  • Ensure compliance with product post-marketing approval requirements.


  • A degree in life science-related discipline.
  • 5 years of relevant experience.
  • Understanding of both legal and scientific matters.
  • Fluent in English.

Job Offer

To be discussed.

Executive po­si­tion, 100%


Michael Page Switzerland

Quai de la Poste 12 1204 Geneva

1204 Geneva

Michael Page

Quai de la Poste 12Genève


Human resources / Personnel services

Michael Page

Quai de la Poste 12Genève


Human resources / Personnel services

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