Regulatory Affairs Specialist | Johnson & Johnson
تفاصيل الوظيفة
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Riyadh Saudi ArabiaJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology were 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 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: Bachelors (.) Degree of Biomedical engineering or Sciences
Experience; min. 2 years
Language: English - Arabic
Key Competencies:
Time Management
Presentation & Communication Skills
Involvement in Regional Projects.
Required Skills:
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-OrientedRequired Experience:
IC
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