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Regulatory Affairs Specialist (Contract)

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Qualifications:

Experience in Medical Devices Regulatory Affairs, Knowledge of UK MDR 2022 compliance, Familiarity with EU MDD and MDR regulations, Expertise in ISO 13485 QMS, Understanding of patents and trademarks.

Key responsabilities:

Create and update technical files and reports
Compile vigilance PMS and PSUR reports
Assist with regulatory submissions and registrations
Liaise with departments for documentation updates
Manage patents, trademarks, and standards database

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Job description

Yolk Recruitment is partnered with a growing medical device manufacturer who have a new opportunity for a Regulatory contractor.

Youll 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.

Youll 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

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/046e71e7bda2edde6a015eef25112cf1