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QA and RA Specialist
View: 109
Update day: 26-03-2024
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
- 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: 10-05-2024
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