Regulatory Affairs Specialist Johnson And Johnson Medtech Orthopaedics

Johnson & Johnson Medtech | Orthopaedics

Leeds, United Kingdom
3d onsite
Knowledge of uk mdd directive and mdr regulation
Experience registering medical devices with mhra
Ability to perform regulatory impact assessments
This role involves monitoring the UK/IRE regulatory environment and ensuring local compliance for Johnson & Johnson Medtech Orthopaedics products

Job Summary

  • This role involves monitoring the UK/IRE regulatory environment and ensuring local compliance for Johnson & Johnson Medtech Orthopaedics products.
  • The successful candidate will be responsible for registering medical devices with the MHRA and managing internal database updates for the UK and Ireland markets.
  • Following a planned separation, employees may transition to become part of the standalone DePuy Synthes company governed by its specific employment policies.

Matching Summary

This role involves monitoring the UK/IRE regulatory environment and ensuring local compliance for Johnson & Johnson Medtech Orthopaedics products.

Skills & Requirements

Must-have

  • Knowledge of UK MDD Directive and MDR Regulation
  • Experience registering medical devices with MHRA
  • Ability to perform regulatory impact assessments

Nice-to-have

  • Working knowledge of MHRA DORS portal
  • Experience supporting tender processes
  • Previous experience as a UK Responsible Person

Key Requirements

  • Degree in Science or Law preferred
  • Fluent in English language
  • Background in medical device regulations

Work Rights

Not specified

Tailored Resume

Cover Letter