Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA
الوصف الوظيفي
Join Johnson & Johnson MedTech as a Regulatory Affairs Specialist in Riyadh, KSA
At Johnson & Johnson, we're driven by our mission to improve health for humanity. Our MedTech division is at the forefront of innovation, combining biology and technology to create smarter, less invasive, and more personalized treatments.
As a Regulatory Affairs Specialist, you'll play a pivotal role in launching medical device products in the Saudi Arabia market, ensuring compliance with regulatory registration and importation guidelines. Your responsibilities will include:
- Preparing and submitting registration, re-registration, and variation product files
- Coordinating SFDA meetings and providing clearance support to distributors
- Updating regulatory tracking systems and managing certificate renewals
- Responding to change impact assessments and conducting copy review processes
- Lifting regulatory restrictions for products and providing tender support
To succeed in this role, you'll need:
- A Bachelor's degree in Biomedical Engineering or Sciences
- Minimum 2 years of relevant experience
- Bilingual proficiency in English and Arabic
- Strong time management, presentation, and communication skills
- Experience in regional projects
Preferred skills include analytical reasoning, brand research, business behavior, design thinking, detail orientation, execution focus, market research, package and labeling regulations, process orientation, product licensing, product packaging design, project management, proofreading software, quality assurance, regulatory affairs management, regulatory compliance, and safety orientation.
يمكن أن يرتكب الذكاء الاصطناعي أخطاءً.