Regulatory Compliance Specialist

2 days ago


Dublin, Dublin City, Ireland TN Ireland Full time

At TN Ireland, we are seeking a highly skilled Regulatory Compliance Specialist to join our team as a Quality Systems Specialist. In this role, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

About the Role:

  • We are looking for an experienced professional with a strong background in quality assurance and regulatory compliance.
  • The ideal candidate will have a deep understanding of FDA 21 CFR Part QSR, ISO, and EU MDR regulations.
  • You will work closely with cross-functional teams to ensure seamless implementation of quality management systems and regulatory requirements.

Your Responsibilities:

  • Support weekly/monthly/quarterly QMS governance reporting.
  • Responsible for collection of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes, and actions.
  • Partner with Central Quality Systems and Compliance (CQSC) to ensure successful deployment of a combination product Quality Management System.
  • Support cross-functional teams with review board meetings (e.g., Change control, Supplier Change, change planning, Standards review planning) and Supplier Quality Agreement updates.
  • Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
  • Ensure timely entry, processing, and closure of quality records in compliance with procedures.
  • Supports Notified Body and Health Authority inspections and compliance.
  • Supports Combination Product Audit readiness initiatives.
  • Support process improvements by gap analysis of existing SOPs or processes against medical device standards and regulations and making updates accordingly.
  • Communicate effectively, both verbally and in writing, internally across departments and with external partners.
  • Comply with the company quality assurance requirements as well as applicable regulatory requirements.

About You:

  • You have a minimum of a bachelor's degree in biological/chemical sciences, biomedical/mechanical engineering, or other related subject.
  • Minimum of 4+ years' experience in Quality in a regulated environment.
  • You have knowledge of the regulatory and compliance requirements of FDA 21 CFR Part QSR, ISO, EU MDR.
  • Familiarity with SAP, Veeva Vault, and Trackwise would be desirable.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.


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