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 jblackham@ckqls.ch, 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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