MDR Regulatory Affairs - Staff Specialist (2 years FTC)

England Temporary
  • Excellent opportunity to work for a leading Medical Devices manufacturer
  • Excellent opportunity to join a dynamic team, working on exciting MDR projects

About Our Client

My client is a global leading medical devices manufacturer, that globally provide medical technologies, with a diverse range of products.

Job Description

  • Participate on multidisciplinary teams and communicate regulatory requirements effectively
  • Be a central resource for Global MDR regulatory teams.
  • Act as a source of knowledge and promote standardized MDR approach through: Creation of road maps to MDR information and guidance documents to aid in submission process
  • Incorporate new learnings into MDR tools / guidance and disseminate to MRD teams
  • Stay abreast of deficiencies and successful responses to update teams to previously accepted responses.
  • Assist with MDR questions and give guidance to teams as needed
  • Act as deployable resources for teams - Support existing reg teams with knowledge of regulations - MDR projects within Business Units - Coach and mentor on EU requirements - Support response to NB on submissions
  • Investigate and recommend solutions to address potential regulatory issues.
  • Assist internal MDR team members with data analysis.
  • Mentor Regulatory Affairs Associates and Specialists
  • Serve as primary regulatory contact to the Business Units for escalated MDR issues
  • Member of Independent Review Team
  • Maintain electronic and paper regulatory files as required by departmental procedure
  • Provide other department support as required by immediate supervisor.

The Successful Applicant

  • Degree; desired four-year college degree in Science or Engineering disciplines.
  • 7+ years medical device industry experience; 5+ years' experience with Class II or higher medical devices
  • Excellent technical writing experience within a medical device environment - essential
  • Attention to detail and accuracy - essential
  • Fluent in English, both written and oral - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel) Excellent analytical ability
  • Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.

What's on Offer

Competitive package available

Remote working

Kelly Percival
Quote job ref
Phone number
+44 1727 730 143

Job summary

Life Sciences
Regulatory Affairs
Healthcare / Pharmaceutical
Contract type
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference