Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA
Skills
About This Role
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, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
We provide an inclusive work environment where each person is considered as an individual.
At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness.
Learn more at https://www.jnj.com/medtech
**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 & distributers
Qualifications / Requirements
- Education: Bachelor’s (B.Sc.) Degree of Biomedical engineering or Sciences
- Experience; min. 2 years
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
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