My client, a well-established medical equipment supplier based in North Dublin, is seeking a dedicated Regulatory and Compliance Co-ordinator.

This is a fantastic opportunity for a eager candiate to contribute to a company known for its commitment to quality, growth and innovation in the healthcare industry.

Key Responsibilities

Manage and document product complaints, maintaining a comprehensive complaints log and coordinating complaint details with relevant departments and regulatory bodies.
Support product recalls and notifications, update the product recall control sheet, and communicate Field Safety Notices as needed.
Review and update regulatory procedures, including GDP and PV requirements, to ensure consistency and compliance across the business.
Collaborate with Senior Management, Commercial, Customer Service, and Warehouse teams to enhance processes, standards, and project delivery.
Assist in the successful execution of Quality audits, such as supplier, ISO, and HPRA audits.
Generate KPIs, reports, and meeting minutes for Quality team meetings.
Ensure product compliance with EU legislation, MDR/IDVR, GDP, PV regulations, and related requirements.
Facilitate and document training on the quality system, standards, and regulations across departments.
Conduct internal audits within departments as required.
Perform additional duties as assigned by Management.
Oversee and record Adverse Events (AEs), Adverse Drug Reactions (ADRs), and PV-related issues and queries, ensuring adherence to regulations.
Approve marketing-related requests, including sponsorships, grants, and training initiatives.
Support the quality team in various roles, including RP, AR, and UKRP responsibilities.

Key Requirements

Regulatory and/or Compliance background desired.
Ability to review legislation and regulations and translate them into company processes.
Experience working as part of a project group / project management.
High level of computer literacy including a good working knowledge of Microsoft Office.
Experience of working in a fast-paced, highly pressurised environment.
Experience in dealing with regulatory bodies would be an advantage.
Experience working in a Medical Device company would be a distinct advantage.
Experience working with Quality Management Systems, ISO and HPRA standards and regulations – ISO9001, ISO13485, ISO27001.
Experience with Environment standards would be an advantage ISO14001.

Perks & Benifits

Bonus structure
Pension and life assurance
Employee Assistance Program for well-being support
Educational assistance and Training Academy for career growth
Enhanced annual leave and life leave options
Supportive colleagues with social events and company outing