Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA
8601-Johnson & Johnson Medical Saudi Arabia Limited Legal Entity
Job Title
Regulatory Affairs Specialist
Location
Riyadh, Saudi Arabia
Job Function
Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: Professional
Job Purpose
The main task of a Regulatory Affairs specialist in Johnson & Johnson is launching of medical device products in the Saudi Arabia market in compliance with regulatory registration and importation guidance.
Responsibilities
- Preparing, compiling and submission of registration/re‑registration product files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable SFDA meetings.
- Clearance support to distributors.
- 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.
- Lifting all regulatory restrictions for products that can be shipped to Saudi Arabia.
- Tender support to commercial teams & distributors.
Qualifications / Requirements
- Education: Bachelor’s (B.Sc.) Degree in Biomedical Engineering or Sciences.
- Experience: Minimum 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
- Proof Reading Software
- Quality Assurance (QA)
- Regulatory Affairs Management
- Regulatory Compliance
- Safety-Oriented
Vacancy posted 4 days ago
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