Collins McNicholas

Regulatory Affairs Specialist

Reporting to the Quality Systems/Quality Compliance Manager, the Regulatory Affairs Specialists develops regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets. The Regulatory Affairs Specialist serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities.

Key Responsibilities:

  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned to support products.
  • Develop global regulatory strategies for medical devices in collaboration with R&D and clinical functions.
  • Advise other functional units (R&D, engineering, marketing, quality etc) of the requirements in each target market.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
  • Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  • Maintains and develops the post-market surveillance process
  • Communicates Regulatory requirements to countries, regions, notified bodies and other regulatory agencies.
  • Management of the clinical requirements for regulatory registrations for products and work as part of a cross-functional team to ensure that they are adequately addressed.
  • Performs additional duties as assigned.

Education and Experience:

  • Third Level Qualification preferably in Science/Engineering; 3 years experience in a regulated industry in a similar role desirable
  • Knowledge of regulatory requirements in accordance with ISO13485 & MDD/MDR.
  • Knowledge of medical device quality standards and guidance documents
  • Good communication and interpersonal skills
  • Ability to present at local departmental meetings
  • Proven problem-solving skills
  • Good computer skills including knowledge of Microsoft Office.

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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