Senior Regulatory Affairs Specialist (Contractor) - MedTech

About the role

Johnson & Johnson MedTech is looking for a Senior Regulatory Affairs Specialist (contractor) based in Seoul. The role coordinates, compiles and submits applications for new products and changes to approved products with regulatory agencies, ensures compliance with their regulations and prepares responses to their questions. It is a fixed-term position of 1 year.

Key responsibilities

• Prepare, submit and monitor applications for new products, changes, renewals and KGMP
• Develop compliant regulatory strategies and assess regulatory impact during the product life cycle
• Interact with regulatory agency personnel to expedite approvals and resolve regulatory matters with limited supervision
• Follow up mandatory registration requirements such as local certificates, sample import and local testing
• Ensure Korean label contents and approve the final Korean label artwork
• Research regulatory requirements, communicate with supervisors and managers, and share best practices and templates with the team
• Provide training and limited supervision of contract resources, and support regional, global and cross-sector projects
• Manage project steps to meet milestones independently or with limited supervision
• Review promotional materials and carry out regulatory impact assessments

Required profile

• Bachelor's degree
• At least 3 years of Regulatory Affairs experience, with medical device RA experience required
• Ability to work effectively with limited supervision and meet deadlines
• Fluent verbal and written Korean and English
• Experience in a multinational or regional company is preferred

Required skills

• Knowledge of regulatory requirements, laws, standards and the regulatory environment
• Regulatory compliance, regulatory development and regulatory affairs management
• Product licensing and risk assessments