Regulatory Affairs Specialist IVD

Location: Chittening

Your new company We are seeking an experienced Regulatory Affairs Specialist to join the Technical Documentation team on a contract basis.

This is an excellent opportunity for a regulatory professional with strong IVD/IVDR expertise to play a key role in the preparation, remediation, and maintenance of technical documentation supporting a complex product portfolio. You will work within a global regulatory environment, collaborating with cross-functional stakeholders to ensure compliance with evolving regulatory requirements. Your new role Compile, review and maintain IVD/IVDR Technical Documentation in line with EU regulatory requirements.

Author and update technical files and associated regulatory documentation. Support technical documentation activities related to a strategic divestment project. Review existing documentation for compliance gaps and support remediation activities. Develop and maintain regulatory content including:
Technical Files / Technical Documentation Summary Technical Documentation (where applicable) Labelling and regulatory content Instructions for Use (IFUs) Collaborate with Regulatory Affairs, Quality, R&D, Clinical, Manufacturing and Product Management teams. Ensure documentation meets regulatory requirements and supports product registrations and life cycle management activities. Participate in internal reviews and regulatory inspections/audits as required. Essential Experience Proven experience working in Regulatory Affairs within the Medical Device or In Vitro Diagnostics (IVD) industry.

Strong understanding of EU IVDR (2017/746) requirements. Hands-on experience compiling Technical Documentation / Technical Files for IVD products. Experience authoring and reviewing technical regulatory documents. Knowledge of design control, risk management and regulatory submission documentation. Ability to work independently within a fast-paced project environment.

Desirable Experience Experience writing or managing Instructions for Use (IFUs). Previous involvement in regulatory remediation, compliance or divestment projects. Experience working within large global life sciences, diagnostics or medical device organisations. Familiarity with document management systems and electronic quality management systems. What you'll need to succeed We're looking for a proactive and detail-oriented regulatory professional who can quickly integrate into an established team and deliver high-quality documentation with minimal supervision.

You will be comfortable managing multiple priorities, engaging with stakeholders across different functions, and driving documentation activities to meet critical project timelines. What you'll get in return Remote working What you need to do now If you have strong IVD/IVDR technical documentation experience, have authored technical files and regulatory documents, and are looking for your next contract opportunity with a global leader in diagnostics and life sciences, we'd love to hear from you.