Regulatory Affairs Specialist Johnson & Johnson MedTech Riyadh - KSA

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Product Submissions and Registration

Job Category

Professional

All Job Posting Locations

Riyadh, Saudi Arabia

Job Description

We are searching for the best talent for Regulatory Affairs Specialist.

Purpose

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 & distributors

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
• Proof Reading Software
• Quality Assurance (QA)
• Regulatory Affairs Management
• Regulatory Compliance
• Safety-Oriented