Regulatory/ Compliance Manager

• Guide, coach, direct and develop direct reports.
• Determine team priorities and resolve any conflicts for department resources.
• Conduct project/team meetings regularly to ensure work programs are tracking to plan, providing information and input, assigning work and resolving any issues.
• Oversee the regulatory strategy implementation and control within the regulatory team.
• Manage and maintain technical documentation for existing Class A and B IVD products, including technical review of documents.
• Manage the internal post-market surveillance and risk management processes.
• Coordination of vigilance reporting for CE-IVD, & any other approved territory reporting ensuring all regulatory reporting timelines are met.
• Manage and maintain existing regulatory clearance/certification and filings in new territories.
• Manage regulatory submission timelines, identify risks and appropriate mitigations.
• Advise on regulatory strategies for existing, changing and non-conforming products in collaboration with R&D, Manufacturing and Technical departments, as appropriate.
• Maintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environment.
• Act as deputy Person Responsible for Regulatory Compliance, as required.

• BSc in Molecular Biology or a relevant discipline.
• Minimum 5 years' experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company.
• At least 2 years' experience managing, or supervising team members.
• Excellent working knowledge of ISO 13485 and IVDR/MDR.
• Ability to manage competing priorities in a fast-paced environment.
• Strict attention to detail in all aspects of the role.
• Ability to interact professionally with all organisation levels.
• Excellent communication and interpersonal skills.

• Knowledge and understanding of software as a medical device and associated guidance and standards.
• Experience engaging with Notified Bodies or international Regulatory Authorities during conformity assessment process.

Adecco Ireland is acting as an Employment Agency in relation to this vacancy.