Regulatory & Compliance Coordinator
JOB_52754441118430Job type
PermanentLocation
Dublin North/MeathWorking Pattern
Full-timeSpecialism
Administrative SupportIndustry
Healthcare & MedicalPay
€38,000-42,000
Regulatory & Compliance Coordinator | €38,000 - €42,000 (DOE) | Dublin 11 | Permanent
Your new company
As Regulatory & Compliance Coordinator, you will join a leading sales, marketing, and technical services company. Their main is to deliver products and solutions to assist healthcare providers achieve optimum clinical outcomes. Your office is in Dublin 11. This is a full-time permanent contract.
Your new role
Your duties will include but are not limited to:
- 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.
- 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.
- 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.
What you'll need to succeed
The ideal candidate will obtain the below:
- Regulatory or compliance background is highly desirable.
- Experience with QM systems such as ISO and HPRA standards and regulations – ISO9001, ISO13485, ISO27001-is advantageous.
- Capable of dealing with all complaints/issues as a professional.
- High degree of confidentiality, organisation and attention to detail.
- Ability to work effectively towards tight deadlines
- Flexibility to assist with other areas / projects / tasks within the organisation.
- Works well on their own initiative.
What you'll get in return
- Competitive salary and bonus.
- Employee Assistance Program
- Pension, Life assurance
- Educational Assistance
- Training and development opportunities
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
#LI-DNI
Regulatory & Compliance CoordinatorJOB_527544411184302024-11-202025-02-18
Talk to Rachel Purcell, the specialist consultant managing this position
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JOB_52754441118430