Regulatory Affairs Specialist (medical devices)

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 https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Riyadh, Saudi Arabia

Job Description:

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

Regulatory Affairs Specialist (Medical Devices)

Location: Riyadh

Contract: full-time

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 distributors
• 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 & distributors

Qualifications / Requirements:

• Education: Bachelor’s (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national