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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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Lifelancer Information Technology & Services Startup https://lifelancer.com/
11 - 50 Employees
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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

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Information Technology & Services
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Technical WritingRisk AnalysisTrademark LawISO 13485 StandardMedical Devices
Are you interested?

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