Regulatory Affairs Specialist (Contract)

Inside IR35 - 4 month initially, extensions possible

UK 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 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

Are you up to the challenge? If you feel you have the skills, experience, and passion to be successful in this role, apply now.

Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive, we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying, then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.