Senior Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00048872
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 10.09.2020
  • Closed Date: 26.02.2021
  • Sector:
  • Location: Basel,
  • Discipline:

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.

Your Background:

  • 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, quoting job ref 48872.

It is essential that applicants hold entitlement to work in Switzerland.

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