Job Description

  • Employment Type:
  • Job Location: Galway
  • Date Posted: Posted 10 months ago

Regulatory Affairs Manager

Responsibilities

·         Working within the QA and RA department and reporting to the QA/RA Director, you will manage registrations and submissions for combinations products.

·         Work with regulatory bodies in Europe, the US, Canada, Asia and South America, observing regulatory activity in these locations and making sure that the site has full compliance for products, systems and the product development process.

·         Manage and develop the Regulatory strategy for the site.

·         Manage CE Mark submissions and any product changes or notifications form regulatory bodies.

·         Prepare 510k regulatory filings and correspondence on submissions.

·         Assist project teams in relation to RA queries, similarly for any queries coming from regulatory bodies.

·         Lead a team of 3-4 people and advise other departments on regulatory requirements if needed.

Requirements

·         Level 8 degree in science or engineering discipline with 6 years or more in regulatory affairs and prior experience in managing a small or large team.

·         Must have a strong understanding of EN ISO 13485:2016, MDSAP and FDA requirements.

·         Candidates can come from a Pharma or Med Device background

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

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