Excellent opportunity for someone with MDR and ISO experience to join this Med Device / Pharma company in Dublin. This role is 5 days a week on site at the beginning, then 2 days a week on site after 6 months. Perm role and the chance to join a lovely team that will be working with sites across Ireland.
Key Responsibilities are not limited to but will include:
- Manage product complaints, maintain a product complaints log, and communicate details of complaints to the relevant departments and regulatory bodies.
- Support product recalls / notifications, maintain a product recall / notification control sheet and communicate details of Field Safety Notices to the relevant departments and regulatory bodies.
- Review and update regulatory procedures including GDP and PV requirements across the Group.
- Liaise with Senior Management, Commercial, Customer Service and Warehouse Managers in reviewing and improving processes, standards and delivery of specific projects as required.
- Assist in the successful completion of Quality audits, including supplier, ISO and HPRA audits.
- Generation of KPIs, reports and minutes for Quality meetings.
- Ensure product compliance with EU legislation, MDR/IDVR, GDP & PV regulations, and requirements.
- Assist with organising and recording training regarding the quality system, applicable standards, and regulations across all departments.
- Conduct internal departmental audits as required.
- Perform any other ad-hoc duties as required by Management.
- Management and recording of AEs ADRs and PV issues, queries, regulations, and requirements.
- Approvals for marketing requests - sponsorship, grants, training.
- Support quality team with other role/requirements i.e., RP, AR & UKRP roles.
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.
