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Employer Hartley People
Job Title Regulatory Affairs Specialist
Description

The Role

  • Responsible for the regulatory support for operations, product development and quality.

  • Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.

  • Develop, documents and implement regulatory submissions plan around product development/line extension goals.

  • Prepare U.S. FDA submissions (e.g., 510(k), IDE) as required and per applicable SOPs.

  • Prepare and update European and international technical files/dossiers/registrations

  • Review Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.

  • Ensure adequate documentation compliance to FDA, European and international regulations and standards.

  • Ensure continuous update and maintenance of the Regulatory Affairs files.

  • Follow company procedures on regulatory requirements.

  • Actively promote compliance to all standards.

  • Prepare and present project updates and technical discussions.

    The Person

  • 3rd level technical/ Science qualification

  • 3 years in a regulatory role in the medical device or pharmaceutical industry

  • Strong knowledge of U.S. and/or European and international regulations and standards covering medical devices.

Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.

For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting.

Hartley People also recruit for similar roles such as Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, New Product Development Co-ordinator, Supplier Assurance Manager.

Location Wexford, Wicklow, Waterford
Date Added 21 days ago
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