Regulatory Affairs Specialist
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Key skills for this role
About the Role
Responsible for regulatory product submissions, compliance, and support for medical devices in Saudi Arabia, requiring analytical reasoning and communication skills.
Key Skills for This Role
Responsibilities
- Prepare, compile and submit registration/re registration product files and variations on time directly in Saudi Arabia or through distributors
- Attend SFDA meetings
- Provide clearance support to distributors
- Update regulatory tracking systems
- Ensure renewed certificates and re registration licenses of expired ones are obtained on time
- Respond to Change Impact Assessments before due dates
- Perform copy review process for promotional materials on time upon request
- Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
- Provide tender support to commercial teams and distributors
Requirements
- 2 to 5 years of experience in regulatory affairs for medical devices
- Knowledge of SFDA registration and importation guidance
- Experience in preparing and submitting registration files
Full Job Posting
Overview
- At Johnson & Johnson, we believe health is everything.
- Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured.
- We are searching for the best talent for Regulatory Affairs Specialist.
- The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.
You will be responsible for
- Preparing, compiling and submission of registration/ re registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
- SFDA meetings.
- Clearance support to distributers.
- Updating the regulatory tracking systems
- Having the renewed certificates & re registration licenses of expired ones on time.
- Responding to Change Impact Assessments before due dates.
- Doing Copy Review process for promotional materials on time upon request.
- Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
- Tender support to commercial teams & distributers
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