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.
To be discussed.