Regulatory Affairs Specialist 12-month FTC

This is a handson 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 invitro diagnostic portfolio. During this fixedterm period youll play an important role in sustaining CE marking supporting IVDR activities and ensuring ongoing compliance within a wellestablished 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 youll be doing:

Regulatory compliance & CE marking

You will take ownership of daytoday regulatory activities applying IVDD and IVDR requirements in a practical businessfocused 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 uptodate 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 fixedterm contract.

• Fulfil PRRC responsibilities in accordance with IVDR Article 15
• Remain available to support regulatory compliance oversight and decisionmaking
• 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 PostMarket Surveillance (PMS) assessments and support associated reporting obligations
• Review and confirm that product labelling and customerfacing information meet applicable regulatory and standards requirements

General responsibilities

• Maintain appropriate housekeeping standards and adhere to Health & Safety requirements
• Support additional QMSrelated activities where required

Qualifications :

What youll bring

• A degree in Science Engineering Quality Assurance or a related field
• 3 years experience in a regulated medical device or invitro 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 problemsolving

If you enjoy applying regulatory detail to realworld 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

Remote Work :

No

Employment Type :

Full-time