I am keen to speak with Compliance Administrative Specialists for this 12-14 Month Maternity Leave Contract (possibility to go Perm).
My client is an established Medical Device Distributor and requires an Administrator to manage the Compliance related issues with the Distribution of Medical Equipment.
You will ideally have a background in Healthcare Compliance / Quality Management Systems / ISO Standards, but I am open to considering a range of candidates who have Administrative / Compliance related experience – APPLY TODAY
Medical Device Compliance Officer / Good Distribution Practice / Compliance Officer / GDP / Health Care Compliance / ISO 9001 / ISO 13485 / Medical Devices Regulation (EU) 2017/745 / QMS / HPRA / Dublin / Ireland
Job Title: Medical Device Compliance Administrative Officer
Reports To: Senior Manager & Director
Location: Dublin Offices / Work from Home Option 50%
- 12-14 Month Fixed Term Contract (Possibility to go Perm)
- € – Basic (Dependent on Experience & Open to Negotiation)
- Contract Completion Bonus (€2,500)
- Profit Share Bonus (Approx. €2,500)
- Health Insurance (VHI)
- Pension (5%/5%)
- Paid Annual Leave (26 Days, plus 9 Public Holidays)
- Signing Bonus (€)
The Compliance Administrator will have responsibility to lead and drive the management and maintenance of The Quality Management System and regulatory systems. You will provide compliance and quality assistance to the highest international standard, across a broad range of areas including ISO and Health Care Compliance. Reporting to a Senior Manager, you will work closely with members of the Business Teams.
Duties and Responsibilities:
- Healthcare Compliance – Leads and drives the Health Care Compliance (HCC) program to ensure business practices are compliant with internal guidelines and regulatory requirements
- Review and approve incoming HCP/Sponsorship requests in line with HCC guidelines
- ISO – General upkeep of the quality system in terms of ISO 9001 and 13485 standards and the online documentation system
- Proposing and implementing improvements to the quality system in line with industry best practices and standards
- Develop and roll-out QMS as required
- Upkeep of the quality system and business practices in terms of Medical Devices Regulation (EU) 2017/745
- Facilitate on-going compliance for the company by assisting in the adherence to the quality manual and internal quality policies
- Co-ordinating and submitting information to customers as requested and supporting the complaints and product recall system from a quality perspective
- Review/lead process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary
- Preparation of Key Performance Indicators for the Quality Department and assisting in the maintenance of records for the company KPIs as per Quality Management review requirements
- Delivery of quality systems and HCC training as required
- Develop and write SOP’s & controlled documents and provide QA approval of procedures and protocols
- Completion of internal audits and supporting the hosting of customer audits (point of audit set up and Quality Department representative during audits)
- Liaise with HPRA as required
- Relevant Third Level qualification
- 3-5 years’ experience working in a Compliance Administrative role
- Experience of working on Medical Device, Pharma, Healthcare Compliance a major advantage (Not Essential)
If you would like to be considered for this fantastic opportunity why not contact me directly on my mobile (See Profile); Just ask for Patrick.
Alternatively, follow the links below and send me your CV.
Key Words: Medical Device Compliance Administrator / Good Distribution Practice / Compliance Officer / GDP / Health Care Compliance / ISO 9001 / ISO 13485 / Medical Devices Regulation (EU) 2017/745 / QMS / HPRA / Dublin / Ireland
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