Senior Regulatory Affairs Manager

Employer
CK Clinical
Location
Basel
Salary
Competitive
Closing date
9 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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 implant dentistry 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 documentation of 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 well as 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 CK Group, quoting job ref 48872.

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

As one of the leading specialist clinical recruitment companies in the UK, CK Clinical is here to help.

Since forming in 2004, CK Clinical has forged special partnerships with many of the top pharmaceutical and biotechnology organisations in the world. Working with a range of businesses from small independent start-ups to global blue chip pharmaceuticals providing quality staff. Our aim to help candidates find their dream clinical job has enabled us to expand into Europe, with us frequently placing people into jobs in countries such as:

  • Belgium
  • Holland
  • France
  • Switzerland
Contact Us
  • 9 High Street
  • Stevenage
  • SG1 3BG
  • GB
  • +44 (0)1438 743047
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