Are you an experienced Regulatory Affairs specialist or Medical Writer? Do you have experience in the writing / authoring of technical files? If so, we would love to speak with you! We are recruiting for a Regulatory Affairs Specialist to join our clients Infectious Disease business unit, preparing documentation for international product registrations. We are looking for someone with an RA or Medical Writing background, preferably within an IVD or medical device manufacturing environment. This role is fully remote within the UK, Inside IR35 and contracted initially until the end of 2025 working 37.5 hours per week. Responsibilities: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Performs regulatory impact assessments.Coordinate with internal and external stakeholders to gather necessary information.Develops regulatory strategies for products in development and for modified products to achieve clearance/approval internationally.Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations.Assesses product, manufacturing, and labeling changes for regulatory reporting