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Regulatory Affairs Manager

LGC Group
County Tipperary
Full time
4 days ago

Company Description

Technopath Clinical Diagnostics, an LGC Clinical Diagnostics company, develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. Our outstanding team, scientific expertise, efficient operations and quality systems support a range of advanced technologies daily, improving patient outcomes.

Job Description

We are seeking a dedicated Regulatory Affairs Manager to join our team in Tipperary, Ireland. This is an exciting opportunity to work with a world-class team and contribute to our reputation for excellence in the IVD industry. In this strategic and hands-on leadership role, you will lead our Regulatory Affairs function, ensuring global compliance and successful product registration in alignment with evolving regulatory standards.

You will drive the implementation of our regulatory strategy, oversee both EU and international submissions (with a strong focus on IVDR), and serve as the designated Person Responsible for Regulatory Compliance (PRRC) under IVDR Article 15.

Key Responsibilities

Qualifications

Additional Information

Our values

Benefits

At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know.

Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry!

All your information will be kept confidential according to EEO guidelines.

Note - The PRRC shall suffer no disadvantage within the organisation in relation to the proper fulfilment of these duties.

#lgcij

 

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