Regulatory Affairs Specialist (Contract)

Regulatory Affairs Specialist (Contract)Inside IR35 - 4 month initially, extensions possibleUK Based, remote with infrequent visits to site.
Part Time - 2/3 days per week.
Yolk Recruitment is partnered with a growing medical device manufacturer who have a new opportunity for a Regulatory contractor.
You'll support a range of regulatory activities, including:Creation and updating of technical files, reports and procedures.Compiling vigilance PMS and PSUR reports.Supporting with world-wide regulatory submissions.Assisting with Competent Authority registrations including the MHRA and ECREP.Liaising with all departments to obtain required documentation for technical file and registration updates.Creating Declarations of Conformity.Reviewing and managing standards database and advising / implementing changes to the technical files as required.Support Management of Patents and Trademarks.Supporting the creation and implementation of compliant Regulatory procedures.You'll need:Previous experience in Medical Devices Regulatory Affairs and knowledge ofUK MDR 2022 UKCA compliance and markingEU MDD9342eec CE compliance and markingUKCA compliance and marking.EU MDR 2017/747 CE compliance and markingEC 60601 family compliance ETL/UL markingISO 13485 QMSISO14971 Risk analysis.Patents and Trademarks