Product Quality & Complaints Coordinator Maternity Leave Contract Cover New

We are currently recruiting for a Product Quality & Complaints Coordinator. This is a hybrid role with 2 days a week onsite and 3 days remote. This is for a maternity leave contract cover.

Role reports to the Regulatory Affairs Manager

Role & Responsibilities:

• Support the Regulatory Affairs Manager in the effective coordination of product quality, vigilance and regulatory compliance activities for products placed on the Irish market
• Manage product quality complaints from initial receipt through to closure, in conjunction with the company’s Global Complaints functions, in accordance with applicable EU/Irish requirements, HPRA guidance and internal procedures.
• Create, maintain and control complete complaint files and records (including supporting evidence, communications and decision rationale) in line with internal requirements and audit readiness expectations.
• Ensure prompt logging and communication of complaints to Global Complaints, including timely escalation of potential serious incidents/priority complaints to appropriate local and global stakeholders within required timeframes.
• Act as a point of contact for customers and internal teams (e.g., Sales/Customer Service) on product quality queries, ensuring accurate information is gathered and responses are provided promptly and professionally.
• Review investigation outputs and draft customer correspondence (where applicable) to communicate investigation findings and outcomes within agreed timelines.
• Support the coordination, implementation and documentation of Field Safety Corrective Actions (FSCAs), product recalls, quality defect investigations and mock recalls, including liaison with Global Safety/Vigilance functions and the HPRA as required.
• Provide support to Pharmacovigilance/Medicovigilance, compliance and regulatory activities as directed, including the triage of adverse event/incident information and onward reporting via the appropriate channels.
• Deliver or coordinate periodic training and awareness activities (as required) for relevant personnel on complaint handling, vigilance awareness and recall/FSCA processes.
• Contribute to the preparation, review and continuous improvement of local procedures and work instructions relating to complaint handling, vigilance and product safety actions.
• Participate in internal and external audits/inspections as required and support the timely completion of any assigned actions.

Skills & Experience Requirements:

• A third-level qualification in a life science, biomedical, pharmacy or related discipline (or equivalent relevant experience).
• Minimum 2–3 years’ experience in a regulated Medical Device and/or Pharmaceutical environment, ideally with exposure to complaint handling, quality systems or vigilance activities.
• Working knowledge of relevant legislation/regulations/guidance applicable in Ireland and the EU (e.g., medical device vigilance expectations and HPRA guidance); familiarity with GDP/QMS principles is an advantage.
• Excellent English communication skills (written and verbal) with the ability to produce clear, compliant documentation and communicate effectively with customers and internal stakeholders.
• Ability to interpret technical information and apply it to complaint assessments, investigation follow-up and customer responses.
• High accuracy and attention to detail, with strong planning, organisation and follow-through to manage multiple priorities and deadlines.
• Proactive and collaborative approach, comfortable working with cross-functional/global teams and balancing competing demands.
• Strong interpersonal skills with the ability to engage professionally with stakeholders at all levels, including external parties (e.g., customers and competent authorities) when required.
• Ability to work both independently and as part of a team, exercising sound judgement and escalating appropriately.
• Demonstrated problem-solving skills with a focus on timely completion, quality of output and continuous improvement.
• Strong Microsoft Office skills; experience with SAP and/or quality/complaints databases is an advantage.

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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