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QA and Regulatory Specialist

  • Gehalt: CHF70 - CHF78 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Zug
  • Berufsbereich: Other, Pharma & Life Sciences
  • Datum der Ausschreibung: 20.02.2019
  • Job ID: BBBH98370
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QA and Regulatory Specialist

On behalf of our client, one of the biggest medical devices company based in Zug we are looking for a QA and regulatory specialist.

This is a contracting position, starting in March until the end of September with extension possibilities.


  • Collaborate with Regulatory OTC - in order to collect the data from the dossiers in regards of the medical devices (for combination products)
  • Collaborate with internal stakeholders (Source QA & Make & Source) the follow up of original communication performed with the EM in regards of suppliers for medical devices
  • Follow up and collect from EMs, the questionnaire sent out in relation with medical devices suppliers
  • Collect samples of the combination products from EMs and consolidate the overview in regards of the artwork information and type of medical device used versus dossier
  • Perform a review of the questionnaires and consolidate an overview
  • Collaborate with EM Make - in order to build the logistic flow for all impacted products under MDR
  • Connect with UDI work stream in regards of the combination products list (to confirm sale forecast)
  • Support additional requests which might come from other WS
  • Support the activity to place QRA between medical devices suppliers
  • Support the preparation of the regular updates within the organization
  • Collect from medical devices suppliers the documentation (as defined)
  • Support QMS workstream - review potential procedures which would need to be updated due to MDR implementat

Your skills/experiences are:

  • BA degree in Life Sciences, Pharmacy or Engineering
  • General knowledge of global regulatory requirements (e.g. ISO 13485, 21 CFR Part 820);
  • Excellent communication skills, verbal and written in English
  • Proficiency in MS office
  • 1-2 years of experience in a multinational environment in the MD / Med-tech industry

If you are a result-oriented QA and Regulatory specialist currently looking for a challenging new position that applies to your skills, then we look forward to receive your application!

I'm always looking for skilled IT Experts so please don't hesitate to send me your CV.

Not the right job for you? Since new jobs are coming in every day just give me a call +41 (0)61 282 22 17. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!

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