Senior Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00048872
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 10.09.2020
  • 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 jblackham@ckqls.ch, quoting job ref 48872.

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

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