Company Description

Technopath Clinical Diagnostics, part of LGC Clinical Diagnostics, develops and manufactures a comprehensive range of diagnostic quality solutions used by laboratories across the life sciences industry.

Our work supports confidence in diagnostic results and contributes directly to improved patient outcomes. We do this by combining scientific expertise, robust quality systems and a culture shaped by our values: Passion, curiosity, integrity, brilliance and respect.

Job Description

This is a hands‑on regulatory role where your expertise directly supports product compliance, patient safety and business continuity.

As Regulatory Affairs Specialist, you will partner closely with Quality, R&D and Operations teams to apply regulatory requirements across our in‑vitro diagnostic portfolio. During this fixed‑term period, you’ll play an important role in sustaining CE marking, supporting IVDR activities and ensuring ongoing compliance within a well‑established quality system.

Are you looking for an opportunity where your regulatory judgement is valued, your decisions have real impact, and collaboration is embedded in how work is done?

What you’ll be doing:

Regulatory compliance & CE marking

You will take ownership of day‑to‑day regulatory activities, applying IVDD and IVDR requirements in a practical, business‑focused way.

Implement and support CE marking activities consistent with IVDD / IVDR
Prepare, update and maintain Technical Documentation / Technical Files for EU and selected global markets
Coordinate product registrations, notifications and certifications, ensuring records remain current and accurate
Provide regulatory input to EU and international Competent Authorities and Regulatory Agencies as required
Support regulatory submissions for markets outside the EU, in collaboration with internal partners

Standards & documentation management

You will help ensure regulatory expectations are understood and consistently applied across the organisation.

Own and maintain a complete, up‑to‑date library of relevant EU Directives, ISO standards, FDA guidance and 21 CFR requirements
Apply regulatory standards appropriately throughout the company, confirming alignment with applicable requirements
Supply regulatory documentation, certifications and supporting evidence upon request

PRRC (IVDR – Article 15)

This role will act as Person Responsible for Regulatory Compliance (PRRC) for the duration of the fixed‑term contract.

Fulfil PRRC responsibilities in accordance with IVDR Article 15
Remain available to support regulatory compliance oversight and decision‑making
Carry out PRRC duties independently and with integrity

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

Quality system & change management

Strong regulatory input is critical to maintaining a robust QMS.

Provide regulatory review and approval for changes impacting the Quality Management System
Support change classification and assessment to ensure continued compliance

Risk management, PMS & labelling

You will contribute to regulatory activities across the full product lifecycle.

Support risk management activities in line with ISO 14971 principles
Perform Post‑Market Surveillance (PMS) assessments and support associated reporting obligations
Review and confirm that product labelling and customer‑facing information meet applicable regulatory and standards requirements

General responsibilities

Maintain appropriate housekeeping standards and adhere to Health & Safety requirements
Support additional QMS‑related activities where required

Qualifications

What you’ll bring

A degree in Science, Engineering, Quality Assurance or a related field
3+ years’ experience in a regulated medical device or in‑vitro diagnostic environment
Solid understanding of IVDD 98/79/EC, IVDR (EU) 2017/746, ISO 13485 and FDA 21 CFR 820
Familiarity with ISO 14971 risk management requirements
Eligibility to act as PRRC under IVDR Article 15
Strong attention to detail, with the ability to prioritise effectively
Clear, confident written and verbal communication skills
A collaborative perspective and a practical approach to problem‑solving

If you enjoy applying regulatory detail to real‑world challenges and value accuracy, integrity and teamwork - this role could be a strong fit!

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.

#lgcij

Work Arrangement: Hybrid

Department: Quality Assurance and Regulatory Affairs

Regulatory Affairs Specialist - 12-month FTC

Benefits

Job Description