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VP of Regulatory Affairs

  • Sector: Medical Devices
  • Contact: Christopher O'Toole
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 17769

Our Galway-based client are looking to hire a VP of RA to help guide and grow their QARA team as they continue to expand in size of company and product range.


Purpose of the role:


  • Ensure NPD activities are aligned with those of the company’s vision, mission, objectives and focus
  • To manage and maintain the Quality Management System and the Operational Quality Requirements
  • Provide Quality and Regulatory direction and support for New Product Research and Development programmes

Responsibilities for this role:


  • Acting as the Management Representative, the responsibilities and authorities of this position include:
  • Ensuring that processes needed for the Quality Management System are established, implemented and maintained.
  • Reporting to Top Management on the performance of the Quality Management System and any need for improvement
  • Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
  • Liaison with External parties on matters relating to the Quality Management System
  • Responsible for the development and implementation of the Corrective and Preventative (CAPA) actions and Audit Systems
  • Compliance of the companies Risk Management Files in accordance to ISO 14971
  • Management of Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions to Notified Bodies, FDA and Competent Authorities
  • Active management within Project Teams to identify the design control and QMS requirements
  • Integration of the commercial requirements of the business with the QMS and project requirements
  • Fostering a strong, interactive and results-driven work environment for the team.
  • Providing support as required for project funding and budget requirements.


For a full job description and more information on this role please contact Chris O Toole for a confidential discussion.

christopher.otoole@collinsmcnicholas.ie

091706713