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 of
• UK MDR 2022 UKCA compliance and marking
• EU MDD9342eec CE compliance and marking
• UKCA compliance and marking.
• EU MDR 2017/747 CE compliance and marking
• EC 60601 family compliance ETL/UL marking
• ISO 13485 QMS
• ISO14971 Risk analysis.
• Patents and Trademarks