Regulatory Manager
Duration:
Full-time, permanent position
Reporting to:
Chief Operations Officer
Location:
Limerick
In this role you will be responsible for driving and managing 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.
If this sounds like an interesting opportunity for you, please get in touch at alan{at}accpro{dot}ie