Regulatory Affairs Specialist Johnson And Johnson Medtech Orthopaedics

Johnson & Johnson Innovative Medicine

Leeds, United Kingdom
Hybrid (3 days in office, 2 days remote)
Uk/ire regulatory environment monitoring
Mhra medical device registration
Uk mdr and eu mdr knowledge
Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist to join their Orthopaedics team in Leeds, UK. The role involves ensuring regulatory compliance for products in the UK and Ireland, focusing on local regulatory requirements and maintaining internal databases

Job Summary

  • This role will involve monitoring of the UK/IRE Regulatory Environment and ensuring local regulatory compliance of products and innovation of processes.
  • Key responsibilities include registering Medical Devices with MHRA, performing UK/IRL impact assessments of regulatory changes, and managing internal database updates for products destined for UK and IRL markets.
  • The ideal candidate will have a degree in Science or Law and a medical device background with knowledge of UK Regulation, MDD Directive & MDR Regulation in EU and UK.

Matching Summary

Match Score: 85

Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist to join their Orthopaedics team in Leeds, UK. The role involves ensuring regulatory compliance for products in the UK and Ireland, focusing on local regulatory requirements and maintaining internal databases.

Skills & Requirements

Must-have

  • UK/IRE Regulatory Environment monitoring
  • MHRA Medical Device Registration
  • UK MDR and EU MDR knowledge
  • Product compliance with legislation
  • Regulatory impact assessments

Nice-to-have

  • Experience as UKRP
  • MHRA DORS portal knowledge
  • Supporting Tenders
  • High degree of initiative
  • Outstanding collaboration skills

Key Requirements

  • Degree in Science or Law
  • Medical device background
  • Knowledge of UK Regulation
  • Knowledge of MDD Directive & MDR Regulation
  • Experience with databases and advanced Excel skills
  • Working knowledge of medical devices regulatory documentation

Work Rights

Not specified

Tailored Resume

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