Job description

We offer a job as a Regulatory Consultant – Medical Devices, in which you will:

  • optimally combine your scientific background and regulatory knowledge
  • work in an international environment of pharmaceutical and medical device/in vitro diagnostics industry
  • prepare and update technical documentation (eg. STED, BSER, CER, RMP) for applications
  • coordinate and manage authorisation procedures and interactions with notified bodies
  • implement and maintain ISO 13485 QMS
  • act as authorized representative
  • perform medical device directive vs. regulation gap analysis
  • be coached by Zwiers
  • live up to the Zwiers “professional approach with a personal touch” spirit

Profile

You have:

  • an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences
  • 2-3 years of experience in the medical device/IVD industry, preferable RA/QA
  • Knowledge of ISO standards; audit experience is a plus
  • eager to learn, develop and excel
  • flexible and pragmatic
  • the ability to handle stringent deadlines
  • writing and editing skills (English)
  • the ability to communicate in a convincing way

Offer

Zwiers Regulatory Consultancy offers a fulltime job, but is willing to discuss a part time contract. Salary will depend on education, knowledge and experience.

Contact

For further information you can contact Alex Zwiers, CEO, at tel. +31 (0) 610489150.
We look forward to your application. You can apply via email: info@az-regulatory.com.

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