Medical Device Expert - Zurich

  • Salary: Competitive
  • REF Number: 00043495
  • Consultant: Jocelyn Blackham
  • Contact: 01438 842962
  • Date Published: 25.09.2018
  • Closed Date: 22.10.2018
  • Sector:
  • Location: Zurich, Switzerland,
  • Discipline:

Jocelyn Blackham is recruiting for a Medical Device Expert to join a young, start up company at their site based in Zurich. This position is offered on a permanent basis.

The main purpose of the role will be to:

  • Support the company's R&D team to establish and implement verified and validated testing and production procedures.
  • Select and manage CRO's and CMO's for external testing and production.
  • Set up quality and regulatory affairs together with an external partner & Legal Manufacturer.
  • Define regulatory strategy, implement the QMS, prepare technical files.
  • Play a key role in internal audits, with assistance from CTO.
  • Set up the pre-clinical and clinical trial unit, conducting pre-clinical trials and partners as well as managing relationships with clinicians and KOLs.

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

  • Previous experience with class II or III products - experience in the Medtech industry would be an advantage.
  • Scientific, engineering or clinical background.
  • Ability to define a protocol as well as setup and conduct a test.
  • Quality and regulatory experience, and an understanding in ISO 14385, ISO 9001, ISO 10993, Technical File, CE-marking, 510k, PMA.
  • Expertise in clinical and pre-clinical trials, study design, V&V matrix, KOL management, ISO 14155, project management
  • Ability to travel

This is an excellent opportunity to join a start up Medical Device company at a critical part of their journey.

For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 417276793 or email jblackham@ckqls.ch. Please quote reference QLS43495 in all correspondence.

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