Regulatory Affairs Specialist - 12-month FTC

Responsibilities

• 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

Requirements

• 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!
• Our values
• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Benefits

Additional Information

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?

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Company Intel

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