Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA
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Key skills for this role
About the Role
Johnson & Johnson MedTech seeks a Regulatory Affairs Specialist to manage medical device product registrations and submissions for the Saudi Arabia market. Responsibilities include preparing registration files, supporting SFDA meetings, and ensuring regulatory compliance.
Key Skills for This Role
Responsibilities
- 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
Requirements
- Bachelor’s (B.Sc.) Degree of Biomedical engineering or Sciences
- Minimum 2 years of experience
- Language: English Arabic
Full Job Posting
Description
- At Johnson & Johnson, we believe health is everything.
- We are searching for the best talent for Regulatory Affairs Specialist.
- The main task 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.
Qualifications / Requirements
- Education: Bachelor’s (B.Sc.) Degree of Biomedical engineering or Sciences.
- Experience; min. 2 years.
- Language: English Arabic.
Key Competencies
- Time Management
- Presentation & Communication Skills
- Involvement in Regional Projects.
Preferred Skills
- Analytical Reasoning
- Brand Research
- Business Behavior
- Design Thinking
- Detail Oriented
- Execution Focus
- Market Research
- Package and Labeling Regulations
- Process Oriented
- Product Licensing
- Product Packaging Design
- Project Management
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