Senior Regulatory Affairs Manager
CK QLS are recruiting for a Senior Regulatory Affairs Manager to join a medical device company focused on the dental industry at their site based in Basel, on a permanent basis.
Company: This company is a leading supplier of products for implantdentistry and restorative dentistry, with an international presence.
Location: This Senior Regulatory Affairs Manager role will be based at our clients site in Basel.
Senior Regulatory Affairs Manager Role:
- Ensure that regulatory requirements for the approval of medical devices are met during the product development process.
- Support the team in the interpretation of regulatory requirements throughout the entire lifecycle of the products.
- Ensure that the technical documentationof the products complies with the respective requirements for medical devices.
- Support in the preparation and execution of audits.
- Support of international product registration.
- Scientific, Medical or Engineering background, or corresponding industry experience.
- Previous experience in regulatory affairs and in international approvals in the field of medical devices or pharmaceuticals.
- Experience in quality management and/or product development is an advantage.· TÜV certified Regulatory Manager or equivalent education.
- Knowledge of MDD 93/42/EEC as well as MDR 2017/745 (product classification, definition of applicable standards, conformity assessment procedures).
- Knowledge of MDD 93/42/EEC as wellas MDR 2017/745 (product classification, definition of applicable standards, conformity assessment procedures).
Apply: For more information or to apply for this Senior Regulatory Affairs Manager position, please contact Jocelyn on 0041 (0) 782 516 595 or email firstname.lastname@example.org, quoting job ref 48872.
It is essential that applicants hold entitlement to work in Switzerland.