eFlexes are exclusively sourcing a Regulatory Affairs/Doc Control Specialist for our client who are based in Limerick. The ideal candidate will have a degree in molecular science with the ability and confidence to undertake all associated responsibilities. Position will be offered on full time permanent basis and will report to Quality Manager. This role will also involve R&D Liaison with R&D teams.
Roles & Responsibilities
• Coordination of post market surveillance/vigilance reporting for CE-IVD marked
products.
• Coordination of risk management activities and documentation for CE-IVD marked
products.
• Communication of specific regulatory requirements and provide regulatory support to
cross functional teams.
• Review and approval of Labelling (labels, Instructions for use, marketing material) for
compliance with applicable regulatory requirements and international standards.
• Assist in preparation & maintenance of technical files for CE-IVD marked products and all
other relevant documentation required to comply with the In vitro Diagnostic Directive,
EU-IVDR and any other national or international regulations which apply to the company.
• Assists in planning and preparation of regulatory submissions for specific target markets
for new products, product changes and re-registrations as required.
• Preparation of regulatory reports for management as required.
• Performs additional duties as assigned.
• Lead and manage the document control function ensuring documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner.
• Serve as the company Training Coordinator to initiate, monitor and record training assignments and completions for all personnel. Maintain metrics and routinely report training status to executive management.
• Oversee and lead the Quality System metrics program to create timely status reports for executive management and ensure key Quality Sub-Systems are being properly maintained.
• Manage the External Standards program to ensure the latest standards are obtained, used, and referenced in reports and protocols.
• Manage the Quality System records storage and archival processes, assist in the record keeping development and tracking of critical quality processes such as CAPA, Complaints, Internal/External audit findings, and Non-Conforming Reports.
• Perform other Quality System duties in support of the Quality Assurance function as needed.
Skills & Experience
• Minimum BSc or equivalent.
• Min 3 years' experience in a regulated Quality Systems/Regulatory role in similar industry.
• Good Knowledge & understanding of IVD/MD Directive and IVD/MD Regulation
• Working knowledge of QMS, audits, CAPA etc.
• Good Knowledge & understanding of FDA 21CFR Part 820
• Ability to work on own initiative.
• Self-motivated and enthusiastic
• Excellent interpersonal skills
• Effective team worker
• Good command of English language (written & verbal)
• Good command of computer packages (e.g. MS Office)
eFlexes is an equal opportunities employer
