REGULATORY AFFAIRS SPECIALISTWEXFORD

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R.T.LANE - RECRUITING TALENT

  • Unit 1, Grandy,
  • MALLOW,
  • CO.CORK
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  • Job reference number:15320549
  • Client ID:RI/rtlane10007
  • Posted on:07-FEB-2018
  • Salary:€€€ excellent
  • Location:WEXFORD
  • Job type:PERMANENT

Benefits: BONUS, PAID HOLIDAYS, PENSION / PRSA, PERM. HEALTH INSURANCE

RA Specialist urgently required for a busy Medical Devices company in the Wexford area.



Role:

  • Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.
  • Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
  • Prepares U.S. FDA submissions (e.g., 510(k), IDE) as required and per applicable SOPs.
  • Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
  • Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
  • Ensures adequate documentation compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.
  • Understand and follow company procedures on regulatory requirements.
  • Provide positive example and actively promote compliance to all standards.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Prepare and present project updates and technical discussions.
  • Education and/or Experience:
  • Third level technical/ Science qualification
  • Min 3 years in a regulatory role in the medical device or pharmaceutical industry
  • Knowledge of U.S. and/or European and international regulations and standards covering medical devices.

This job originally appeared on RecruitIreland.com