Senior Regulatory Affairs Specialist

  • Salary: Up to 100 CHF per hour (all inc)
  • REF Number: 00049467
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 14.12.2020
  • Sector: Medical Devices
  • Location: Oberdorf, Basel Area
  • Discipline: Clinical - Regulatory Affairs

CK QLS are recruiting for a Senior Regulatory Affairs Specialist to join a leading medical device company based at their site in Oberdorf on a contract basis until the end of 2021.

Senior Regulatory Affairs Specialist Role: The main purpose of the role will be to:

  • Support MDR compliance execution work by creation/update Technical Documentation of existing devices to comply with MDR requirements.
  • Identify, create, update, review and/or approve reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Instructions for use, labeling and Declaration of Conformity.
  • Coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.

Further responsibilities will include:

  • Identifying and adhering to policies, procedures and work instructions which support technical documentation activities.
  • Supporting preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required.
  • Working with cross-functional teams to obtain relevant informationand subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Regulatory experience in European Medical device industry. Proficient knowledge of MDR strongly preferred.
  • Strong knowledge of ISO 13485.
  • Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).
  • Reasonable knowledge of FDA requirements and possibly registration requirements in further.

This is an excellent opportunity to join a global medical device company.

Apply: For more information or to apply for this Senior Regulatory Affairs Specialist position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email, quoting job ref 48709.

Please could you send any correspondence in English.

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

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