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

Regulatory Compliance & CE Marking

Execute and complete tasks required for CE marking activities in accordance with IVDD/IVDR.
Prepare, update, and maintain Technical Documentation/Technical Files for EU and global submissions.
Provide required information to EU and international Competent Authorities and Regulatory Agencies for product registration and submissions.
Maintain up‑to‑date status of product registrations, notifications, and certifications.
Coordinate product registration activities for markets outside the EU.
Ensure the organization’s ongoing compliance with FDA QSRs, 21 CFR requirements, ISO 13485, and other applicable global regulations.

Standards & Documentation Management

Maintain a complete and current library of applicable EU Directives, EU/ISO standards, FDA Guidance Documents, and 21 CFR regulations.
Confirm understanding of relevant standards and ensure appropriate application within the organization.
Supply regulatory documentation, certifications, and supporting records upon request.

PRRC Responsibilities

Act as the designated Person Responsible for Regulatory Compliance (PRRC).
Remain continuously and permanently available for PRRC responsibilities.

Quality System & Change Management

Provide regulatory input and approval for changes impacting the QMS, including the classification of changes.

Risk Management & Post‑Market Activities

Contribute to risk management activities throughout the product lifecycle.
Perform Post‑Market Surveillance (PMS) assessments and support related reporting obligations.

Labelling & Customer-Facing Information

Ensure all labelling meets applicable regulatory and standards requirements.

General Responsibilities

Maintain proper housekeeping and adhere to Health & Safety requirements.
Support additional tasks related to Technopath’s QMS as required.

Qualifications

Minimum of degree qualification in relevant Science, Engineering or Quality Assurance discipline

3+ years’ experience working in a regulated medical device/ in vitro medical device environment.

Thorough knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC, and international regulatory requirements

Familiar with ISO 14971

Meet requirements to act as person responsible for regulatory compliance as per (EU) 2017/746 (IVDR) - Article 15

Strong interpersonal skills and the ability to communicate well both verbally and in writing.

Excellent attention to detail and ability to prioritise.

Minimum B.Sc. in Science/Engineering/QA or related discipline.

Strong initiative and troubleshooting skills required.

Additional Information

Our values

PASSION
CURIOSITY
INTEGRITY
BRILLIANCE
RESPECT

Benefits

25 days holidays
Life assurance & health allowance
Discounts with local and national retailers
Free 24/7 Employee Assistance Programme
Recognition schemes and monetary awards

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

Work Arrangement: Hybrid

Department: Quality Assurance and Regulatory Affairs

Regulatory Affairs Specialist

Benefits

Job Description