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