Regulatory Affairs Specialist Johnson And Johnson Medtech Orthopaedics

Johnson & Johnson Medtech | Orthopaedics

Leeds, United Kingdom
Hybrid (3 days in office, 2 days remote)
Uk regulatory environment monitoring
Mhra medical device registration
Uk/ire regulatory compliance
Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist for their Leeds office, focusing on ensuring local regulatory compliance for medical devices in the UK and Ireland. The role involves monitoring the regulatory environment, managing product registrations, and collaborating with various partners to maintain compliance

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 monitoring of and execution according to local regulatory requirements and advising appropriate partners.
  • Ensuring J&J standard requirements and project timelines are met.

Matching Summary

Match Score: 85

Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist for their Leeds office, focusing on ensuring local regulatory compliance for medical devices in the UK and Ireland. The role involves monitoring the regulatory environment, managing product registrations, and collaborating with various partners to maintain compliance.

Skills & Requirements

Must-have

  • UK Regulatory Environment monitoring
  • MHRA Medical Device Registration
  • UK/IRE regulatory compliance
  • Medical device regulatory documentation

Nice-to-have

  • UKRP experience
  • MHRA DORS portal knowledge
  • Tender support experience
  • 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
  • Knowledge of changes to devices
  • Advanced Excel skills
  • Fluent in English

Work Rights

Not specified

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