Regulatory Affairs Specialist

Regulatory Affairs Specialist – Saudi Arabia

Life Unlimited.

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

We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited! Our products are in 100 countries globally, and supporting this takes a huge effort.

What will you be doing?

We are looking for a Regulatory Affairs Specialist to join our team in Riyadh, Saudi Arabia. In this role, you will be responsible for ensuring timely product registrations and maintaining regulatory compliance across the MENA region, with a primary focus on Saudi Arabia.

Working closely with health authorities, distributors, commercial teams, and Global Regulatory Affairs colleagues, you will play a key role in securing market access, maintaining product registrations, and ensuring compliance throughout the product lifecycle.

What will you need to be successful?

• Strong understanding of medical device regulations and registration requirements within Saudi Arabia and the wider MENA region.
• Ability to manage regulatory submissions, renewals, and compliance activities efficiently and accurately.
• Commitment to maintaining compliance with local regulations, quality standards, and company policies.
• Knowledge of ISO 13485, Good Distribution Practice (GDP), and post-market surveillance requirements.
• Ability to build and maintain effective relationships with regulatory authorities and key business stakeholders.
• Strong communication skills with the confidence to collaborate across local and global teams.
• Ability to provide regulatory guidance that supports business objectives while ensuring compliance.
• Proactive approach to identifying and mitigating regulatory risks.

Successful candidates would need the following:

• Bachelor's Degree in Biomedical Engineering, Pharmacy, or a related scientific discipline.
• Saudi Arabian National.
• Minimum of 1 year of experience in Regulatory Affairs within the medical device industry.
• Proven experience supporting regulatory submissions and product registrations.
• Strong knowledge of SFDA regulations and regulatory requirements across the MENA region.
• Familiarity with Quality Management Systems, including ISO 13485 and Good Distribution Practice (GDP).
• Understanding of post-market surveillance obligations and regulatory compliance requirements.
• Experience supporting tender submissions and import permit activities is advantageous.
• Proficiency in Microsoft Office applications.
• Fluent in English, both written and spoken.
• Strong analytical, organisational, and problem-solving skills.

You. Unlimited.

165 years of pioneering innovation requires a relentless focus on what’s next. We’re focused on you. You’re what’s next...

• Inclusion, Belonging and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• Your Future: Annual Performance Bonus and Provident Fund Scheme, Share Save Options.
• Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
• Your Wellbeing: Medical Aid and an Employee Wellness Programme and much more.
• Flexibility: Hybrid Working Model (For most professional roles).
• Training: Hands-On, Team-Customised, Mentorship.

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