Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Contract
Location: Ireland, Ireland
Salary: Competitive
Start Date: 2019-09-17
Reference: BH-115894
Contact Name: Gregory Robertson
Contact Email:
Job Published: September 18, 2019 15:56

Job Description

My client, an established Medical Device company in Ireland are looking for experienced Regulatory Affairs Professional to join them on a contractual basis (6 to 12 months).


Senior Regulatory Affairs Associate | Key Requirements:

  • Develop and advise on regulatory strategies for existing and changing products
  • Maintenance of existing CE mark, IDE and PMA files, including US FDA annual reports, EU Substantial Change Notifications, and Post Market Surveillance Reports
  • Produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with continuous improvement programmes and/or changes required through standards.
  • Investigate, remediate and successfully conclude all regulatory issues that are product related.
  • Support the regulatory team in processing global product registrations and approvals for chosen markets
  • Support Risk Management activities
  • Play an active role in the company’s EU MDR compliance program
  • Management and supervision of MDR, vigilance and clinical safety reporting activities (US & EU)
  • Reviewing and approving labelling changes
  • Ensure personal compliance with internal regulatory, quality and other procedures.
  • Ensure the company is compliant to global regulatory requirements for quality systems and product registrations

Senior Regulatory Affairs Associate | Key Requirements:

  • A minimum of 5 years’ experience working within the medical device industry (Class III)
  • Excellent communication skills
  • Educated to degree standard