Regulatory Affairs Manager

ConvaTec Group

Seoul, South Korea
Onsite
Develop regulatory strategy
Manage regulatory compliance activities
Compile and submit regulatory submissions
Develop regulatory strategy and update the strategy based upon regulatory changes and business needs

Job Summary

  • Develop regulatory strategy and update the strategy based upon regulatory changes and business needs.
  • Manage and execute regulatory compliance activities as required by the local regulations.
  • As part of our team, you’ll enjoy a range of benefits designed to support your wellbeing, growth, and success.

Matching Summary

Develop regulatory strategy and update the strategy based upon regulatory changes and business needs.

Skills & Requirements

Must-have

  • Develop regulatory strategy
  • Manage regulatory compliance activities
  • Compile and submit regulatory submissions
  • Monitor and submit applicable reports
  • Interact with local health authorities
  • Manage product lifecycle maintenance

Nice-to-have

  • Values innovation and collaboration
  • Continuous growth mindset
  • Support product safety issues
  • Support commercial team needs

Key Requirements

  • Minimum 5 years of experience
  • Bachelor/master's degree in science
  • Regulatory Affairs Certification (RAC) preferred
  • Experience in medical device regulatory affairs
  • Knowledge in regulatory submissions to local authority
  • Knowledge in Quality Management System

Work Rights

Not specified

Tailored Resume

Cover Letter