QA and RA Specialist

☞ Make A Healthy Change

View: 119

Update day: 20-03-2024

Location:

Category: Quality Assurance / Quality Control

Industry:

Position: Entry level

Job type: Full-time

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Job content

We are looking for a QA & RA Specialist for our client active in the medtech industry.

It is a permanent position in Neuchâtel.

Your Main Responsibilities
  • You will be the only contact for product registration and regulatory affairs for the internal departments;
  • You will prepare the documentation for product registration and change notifications in defined countries and ensure follow-up;
  • You prepare and update the summary technical documentation for all the products to ensure compliance with current regulations
  • You perform regulatory survey
  • You prepare and will do the follow-up of post-market clinical studies (PMCF) according to current regulations: preparation of documentation, submission to ethical committee and monitoring
  • You support the preparation of Post Market Surveillance documentation as per Medical Device Regulation
  • You support that quality management system meets standards, including : document control, change control, complaint handling, non-conformities/CAPA, vigilance, trainings, risk analysis and validation plan
  • You support the Quality Manager in flash audits, internal and external audits, and unexpected audits
Your Qualifications
  • You have minimum 3 years’ experience in Regulatory Affairs in a medical device industry
  • You have a good knowledge of the Medical Device Regulation MDRand ISO13485 standard
  • You have an excellent level of verbal and written French and English, other languages are a plus
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Deadline: 04-05-2024

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