Regulatory Affairs Specialist

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Regulatory Affairs Specialist is responsible for ensuring timely product registration and sustained regulatory compliance across the MENA region, with a focus on Saudi Arabia. This role supports business continuity by securing licenses, handling regulatory submissions, and maintaining positive relationships with local health authorities.

What will you be doing?

• Secure timely registration of new products in accordance with strategic plans.
• Ensure uninterrupted market access through proactive license renewals and tender documentation support.
• Monitor and interpret new and existing regulations, ensuring business alignment and readiness.
• Manage post-market regulatory activities and documentation to uphold compliance.
• Identify and mitigate regulatory risks impacting product lifecycle or market access.
• Maintain positive relationships with health authorities and regulatory bodies across the region.
• Collaborate cross-functionally with Global RA, distributors, and commercial teams to streamline regulatory processes.
• Support regulatory activities for import permits and tender submissions.
• Maintain and update central regulatory databases and product information systems.
• Contribute to the development of regional regulatory strategies in alignment with global objectives.
  
  
  

What will you need to be successful?

• Bachelor’s degree in Biomedical Engineering, Pharmacy, or a related
• Saudi Arabian nationality
• Minimum 1 year of experience in regulatory affairs for medical devices.
• Consistent track record in regulatory submissions and compliance with regional health authority requirements.
• In-depth knowledge of SFDA regulations and MENA regional requirements.
• Familiarity with Quality Management System requirements in accordance with ISO 13485 and Good Distribution Practice (GDP).
• Strong understanding of post-market surveillance obligations.
• Experience with product registration and documentation for the KSA market.
• Proficient in English (written and spoken)
  
  
  

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

Inclusion and Belonging: committed to welcoming, celebrating and thriving on diversity, learn more about our Employee Inclusion Groups on our website

Your Future: annual bonus, company stock saving plan

Work/Life Balance: paid volunteering hours, flexible approach

Your Wellbeing: Employee Assistance Program

Flexibility: possibility of working in hybrid model

Training: Hands-On, Team-Customized

Extra Perks: referral bonus, recognition program, mentoring program

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