Regulatory Affairs Specialist | Johnson & Johnson Medtech | Riyadh - Ksa

Johnson & Johnson Medtech

Riyadh, Saudi Arabia
Not specified (assumed to be on-site based on the job location).
Sfda regulatory registration and importation guidance
Medical device product launch in saudi arabia
Preparation of registration and variation submission files
Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist in Riyadh, Saudi Arabia. The role involves launching medical device products in compliance with regulatory guidelines, requiring a background in biomedical engineering or sciences and a minimum of two years of relevant experience

Job Summary

  • The primary purpose is to launch medical device products in the Saudi Arabia market while ensuring full compliance with SFDA regulatory registration and importation guidance.
  • Responsibilities include preparing and submitting registration files, managing re-registration licenses, and supporting distributors through clearance processes and change impact assessments.
  • The role requires strong time management and communication skills to handle promotional material reviews, tender support, and maintaining updated regulatory tracking systems.

Matching Summary

Match Score: 85

Johnson & Johnson Medtech is seeking a Regulatory Affairs Specialist in Riyadh, Saudi Arabia. The role involves launching medical device products in compliance with regulatory guidelines, requiring a background in biomedical engineering or sciences and a minimum of two years of relevant experience.

Skills & Requirements

Must-have

  • SFDA regulatory registration and importation guidance
  • Medical device product launch in Saudi Arabia
  • Preparation of registration and variation submission files

Nice-to-have

  • Analytical reasoning and detail-oriented approach
  • Project management and process oriented skills
  • Experience with regional projects and tender support

Key Requirements

  • Bachelor's degree in Biomedical Engineering or Sciences
  • Minimum 2 years of relevant experience
  • Fluency in English and Arabic languages

Work Rights

Not specified

Tailored Resume

Cover Letter