For our client, a medical devices company, localized in the canton of Geneva, we are looking for a:
Regulatory Affairs and Quality Specialist - Medical Devices
- Oversee the department's management and promotion of the Quality System
- 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 organization.
- Ensure regular update and management of the Quality Manual.
- Implement requirements, both internally and towards external partners and suppliers.
- Provide technical & quality support to sub-contractors and verify that standards are met.
- Take part in the design and realization/industrialization of the products
- Manage internal and external audits.
- Ensure that nonconformities and vigilance cases are handled promptly and correctly.
- Release batches of medical devices for sale.
- Organize an annual Quality Management Review.
- Providing the necessary training to ensure employees understand QMS.
- Degree in life science-related discipline
- At least 5 years EU Medical device regulatory affairs experience
- Quality Management System development and operation.
- MDD Medical Device Technical File development and administration.
- ISO13485, ISO14971 Medical Device Risk Management.
- Clinical Evaluation
- Post Marketing Clinical Follow Up
- English: Fluent, French is a plus