Regulatory Affairs Specialist

Regulatory Affairs Specialist – Saudi Arabia, Life Unlimited division of Smith+ Nephew.

Responsibilities

• Ensure timely product registrations and maintain regulatory compliance across the MENA region, with a primary focus on Saudi Arabia.
• Work closely with health authorities, distributors, commercial teams and Global Regulatory Affairs colleagues to secure market access, maintain product registrations and ensure compliance throughout the product lifecycle.
• Manage regulatory submissions, renewals, and compliance activities efficiently and accurately.
• Provide regulatory guidance that supports business objectives while ensuring compliance.
• Identify and mitigate regulatory risks proactively.

Qualifications

• 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 ISO13485 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.
• Strong communication skills with the confidence to collaborate across local and global teams.

Benefits

• Annual Performance Bonus.
• Provident Fund Scheme.
• Share Save Options.
• Flexible Vacation and Time Off.
• Paid Holidays and Paid Volunteering Hours.
• Medical Aid and an Employee Wellness Programme.
• Hybrid Working Model for most professional roles.
• Hands‑On, Team‑Customised, Mentorship training.