Regulatory Affairs Specialist

Smith & Nephew

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)