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.

Description

  • 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.

Profile

  • 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.

24.06.2020
Executive po­si­tion, 100%

Contact

Michael Page Switzerland

Quai de la Poste 12 1204 Geneva

1204 Geneva


Michael Page

Quai de la Poste 12Genève

Industry

Human resources / Personnel services

Michael Page

Quai de la Poste 12Genève

Industry

Human resources / Personnel services
Salary

Salary Check

Take advantage of the jobup.ch service to find out how much you earn as Regulatory Affairs Specialist.

This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.