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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Contract
Location: Limerick
REF: 84933
Job Published: about 2 years ago

Job Description

Regulatory Affairs Specialist

Our client requires two RA Specialists for both Cork and Limerick sites.
  • Medical Device Vigilance reporting and follow up filing to the appropriate competent authorities per timelines required by the Medical Device Directive.
  • Co-ordinate activities related to Product Field Actions by ensuring compliance with current regulatory requirements and corporate procedures.
  • Liaise with competent authorities to provide required information when requested
  • Provide technical data to all locations in support of country specific product registrations and regulatory requirements.
  • Assess proposed changes for regulatory implications and implementation of identified actions to maintain product registrations in impacted countries.
  • Co-ordinate preparation, take participation in and complete follow up for regulatory/recall related activities and procedures for internal, Corporate and third party external regulatory compliance audits.
  • Co-ordinate CE Marking activities with US Regulatory personnel, including new submissions and file modifications as required.
  • Maintain regulatory control for supply of medical devices to regulated markets.
  • Lead & Participate in cross-plant and divisional project teams in areas of compliance and quality systems improvement.
  • Prepare quality reviews and trending activities

Education, Experience and Skills:
  • Degree/Diploma in Quality Management or equivalent discipline is required.
  • Minimum of 2 years? experience in a Quality Assurance compliance position is required; exposure to Regulatory Agencies such as the FDA and/or Notified Bodies is desired.
  • Excellent communication, organisation and time management skills with the ability to manage several priorities at once will be required as will a high level of flexibility with a high level of commitment to success.
  • High level of PC skills required

For further information on this Regulatory Affairs Specialist role in Cork & Limerick please contact Cliona O?Malley on 091730022 /
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