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 / firstname.lastname@example.org
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