Regulatory and Compliance Co-Ordinator
We are seeking a dedicated Regulatory and Compliance Co-ordinator to contribute to our company's 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 & Benefits:
* 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 outings.
The salary range for this position is €40,000 - €60,000 per annum, depending on experience.