Regulatory Manager

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Regulatory Manager

Full-time, permanent position

Reporting to the Chief Operations Officer

Serosep Ltd., have a requirement for a Regulatory Manager who will drive and manage the regulatory team ensuring the company is compliant in all regulatory and legal requirements.

Main Duties:

• 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.

Essential Criteria:

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.

Desirable Criteria:

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.

Job Types: Full-time, Permanent

Pay: €70,000.00-€85,000.00 per year

Benefits:

• Bike to work scheme
• Company events
• Company pension
• Employee assistance program
• On-site parking
• Wellness program

Ability to commute/relocate:

• Limerick, County Limerick: reliably commute or plan to relocate before starting work (required)

Work Location: In person