Director Regulatory Affairs & Quality Assurance Barcelona/The Netherlands

Derks & Derks

Unique opportunity: living in Barcelona or The Netherlands | well funded Medical Devices startup

Offer
  • Setting up a new medical company with a solid financial basis
  • Become the expert on RA and QA for this promising company
  • Visit Barcelona regularly or relocate
  • Mix your talents in management, projects, engineering, RA and QA
  • A good financial package
Organization

Our client, a solid European Medical Device startup with a very innovative, minimally invasive approach to a life-threatening cardiovascular disease is now looking for their Director of Regulatory Affairs & Quality Assurance. This individual will be a senior level regulatory and quality affairs generalist who has successfully cleared FDA medical devices and has seen the pitfalls and delays caused by outdated mindsets and processes. Reporting to the COO, the successful candidate will be a key member of the company’s Management Team and will join the company at their headquarters. Relocation to Barcelona is a possibility, but not a necessity: working at home and visit Barcelona regularly is a serious option.

Position

A unique job in Barcelona: set up the RA and QA of a solidly financed medical devices startup. You’ll slit your time between managing the company’s Regulatory Affairs/Quality Assurance and providing the engineering and product teams with input on how to build the best compliant products out there. As a member of the Management Team you will be involved in much of what is necessary to setup this company. A high end job, with its accent on RA and QA, but on building a business as well.

Profile
  • You have experience with endovascular devices and the unique challenges that go along with their development
  • You have 5-10 years experience with RA/QA, associated with medical device development (cardio/neuro/vascular products being a plus)
  • You’ve written quality documents (SOPs, WIs, templates, etc.) from scratch and know and follow industry best practices when appropriate
  • You are, nevertheless, also open to new ways of looking at regulatory and quality activities. You aren’t shy about challenging the old ways of thinking, as long as the new way is still compliant
  • You are comfortable taking a Class III device through the approval process and have experience with international regulations
  • You have working knowledge of most of these buzzwords, and are probably an expert in a handful of them: 21CFR pt 820 / ISO 13485, CE Mark, Design & Document Control, ISO 14971 Risk Management,
    FDA Pre-Submissions and 510(k) applications
Response

Interested? Please send your resume and motivational letter by email, with reference to WK/18-024-DD, to
Mr. Jan Derks : info@derksenderks.nl. For further information, please call Mr. Derks at number +31 (0)33 472 80 87. As a member of www.inrals.com, Derks & Derks collaborates with LIM Global in Spain. Your resume will be shared with this agency and processed under GDPR guidelines.

An individual assessment may be part of the selection procedure.

Our Inrals partner has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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