Regulatory Manager

Regulatory Manager

Our client, a leading diagnostic specialist, based in Limerick, 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.

So, if you are an experienced Regulatory Manager who wants to make a significant impact and contribute to the success of a dynamic organisation, please apply today!!

The Role:

Reporting to the Chief Operations Officer, the Regulatory Manager responsibilities will include the following:

·      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

Skills & Experience that we need:

·      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- Desirable

·      Experience engaging with Notified Bodies or international Regulatory Authorities during conformity assessment process – Desirable

The Offer:

This is a permanent, onsite role, based in Limerick, with salary to reflect the candidates experience, with excellent benefits package.

This is a fully onsite role based in Limerick so candidates should be based locally or a commutable distance.

How to Apply:

If you are interested in applying, or want to know more about this role please contact,

Orlaigh FitzGerald-Quinn in Cpl Limerick on 085 801 7135 or email your CV to [email protected].

For a full list of our open jobs, please have a look at cpl.com.

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