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 in Riyadh to manage medical device product registrations and submissions with the SFDA. Requires a Bachelor's degree in Biomedical Engineering or Sciences and 2+ years of experience.
Key Skills for This Role
Responsibilities
- Prepare, compile and submit registration/re registration product files and variations on time directly in Saudi Arabia or through distributors
- Attend SFDA meetings
- Provide clearance support to distributors
- Update regulatory tracking systems
- Ensure renewed certificates and re registration licenses of expired ones are obtained on time
- Respond to Change Impact Assessments before due dates
- Perform Copy Review process for promotional materials on time upon request
- Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
- Provide tender support to commercial teams and distributors
Requirements
- Bachelor’s (B.Sc.) Degree of Biomedical engineering or Sciences
- Minimum 2 years of experience in regulatory affairs or related field
- Fluency in English and Arabic
- Time Management skills
- Presentation & Communication Skills
- Involvement in Regional Projects
Full Job Posting
Job Description 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.
- Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions.
- 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.
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.
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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