Regulatory Affairs Specialist
Riyadh, Riyadh Province, Saudi Arabia · Full Time
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- Experience
- 2+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 2 weeks ago
- Work mode
- In office
- Education
- B.Sc. in Biomedical Engineering or Sciences
- Eligibility
- Candidates with a bachelor’s degree in Biomedical Engineering or Sciences and at least 2 years of relevant experience who can work in English and Arabic may apply.
- Resume
- Required to apply
Where you'll work
Job description
About Johnson & Johnson MedTech
Johnson & Johnson is focused on improving health through innovation that helps prevent, treat, and cure complex diseases. The company works across Innovative Medicine and MedTech to create smarter, less invasive, and more personalized solutions that aim to improve outcomes for people worldwide. It also emphasizes an inclusive culture that values each employee’s individuality, diversity, dignity, and contribution.
Role Overview
This position sits within the Regulatory Affairs group, specifically the regulatory product submissions and registration function. The role is centered on supporting the launch of medical device products in the Saudi Arabian market while ensuring compliance with local regulatory registration and import requirements.
Key Responsibilities
- Prepare, assemble, and submit product registration, re-registration, and variation files either directly in Saudi Arabia or via J&J distributors when needed.
- Participate in meetings with SFDA.
- Provide clearance support to distributors.
- Keep regulatory tracking systems up to date.
- Ensure renewal of certificates and re-registration of expired licenses is completed on time.
- Respond to change impact assessments before deadlines.
- Carry out copy review for promotional materials when requested and within required timelines.
- Remove regulatory barriers so products can be shipped into Saudi Arabia.
- Support commercial teams and distributors with tender-related activities.
Qualifications
The role requires a bachelor’s degree in Biomedical Engineering or a science-related field, along with at least 2 years of relevant experience. Strong English and Arabic language ability is required.
Core Competencies
Applicants should be able to manage time effectively, communicate and present clearly, and contribute to regional projects.
Additional Skills and Focus Areas
The position values analytical thinking, attention to detail, market and brand research, business understanding, design thinking, process orientation, execution focus, proof reading, product licensing, package and labeling regulations, product packaging design, project management, quality assurance, regulatory compliance, regulatory affairs management, and a safety-oriented mindset.
Work Environment
This is a professional, full-time, onsite role based in Riyadh, Saudi Arabia.