Senior Regulatory Officer

Senior Regulatory Officer Industry: Medical Device

Department: Regulatory Affairs

Role Summary – Major Activities: Provide coaching and support to all employees on the regulatory team. Ensure employees understand their duties/delegated tasks. Prepare and maintain IVDR compliant technical files utilising information from cross functional teams for IVD Products (Class A – D). Assist in IVDR projects, representing Regulatory Team on cross-functional team. Represent the regulatory team on all new product development and change controls to ensure device is compliant to appropriate regulatory requirements. Review all project documentation across multiple projects and final sign off as regulatory representative. Ensure all deadlines are on target/met. Track and control all regulatory submissions for product changes or renewals for device certification. Coordination of risk management activities and documentation for CE-IVD marked products. Approve all labelling (labels, instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI. Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), procedures etc. Review complaints for regulatory reporting for CE-IVD marked products. Prepare reports for Regulatory Manager/Senior Management as required. Key Competencies of Role: BSc in science/molecular biology or related discipline. 3 – 5 years' experience working in a Medical Device or In Vitro Diagnostic Company. Excellent communication and interpersonal skills. Ability to manage competing priorities in a fast-paced environment. Strict attention to detail. Ability to work to tight deadlines. Location: Limerick (Hybrid Working arrangement)

Contractor Duration: Full time permanent role

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