Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00047813
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 12.03.2020
  • Sector: Medical Devices
  • Location: Basel Area
  • Discipline: Clinical - Regulatory Affairs, Technical - Validation

CK QLS are recruiting for a Regulatory Affairs Manager to join a Medical Device company within dentistry at their site based in Basel on a permanent basis.

Company:

This company is a globally recognised manufacturer of medical devices within the dental industry.

Location:

This Regulatory Affairs Manager role will be based at our clients site in Basel.

Regulatory Affairs Manager Role:

  • Ensure that regulatory requirements for the approval of medical devices are met during the product development process.
  • Complete regulatory content of product-related information and its release.
  • Support and advise brand managers throughout the entire lifecycle of the products in regulatory terms and ensuring that the technical documentation of the products complies with the regulatory requirements for medical devices.
  • Assessment of all products with regard to their risk potential.
  • Support of international registration submissions.

Your Background:

  • Knowledge of MDD 93/42/EEC (product classification, definition of applicable standards, conformity assessment procedures) and other relevant regulations (e.g. the future MDR 2017/745).
  • Previous experience within regulatory affairs within medical technology or pharmaceuticals is desired.
  • Previous experience in quality management and/or product development is an advantage.
  • Qualifications in scientific studies, engineering, medicine or corresponding industry experience.
  • German and English proficiency written and spoken are essential.

Apply:

For more information or to apply for this Regulatory Affairs Manager, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 47813.

Please send all of your correspondence in English.

It is essential that applicants hold entitlement to work in the country where the services will be delivered.

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