Regulatory Approval Specialist

Regulatory Approval Specialist - Dubai

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?

This role is responsible for ensuring product registrations, market continuity and regulatory compliance in GCC markets. It also ensures compliance to Quality Management System and supporting in quality improvement that focuses on quality problems that may affect patient safety by handling complaints reporting, Quality Holds & Field Actions, and all around Quality Management System aspects.

What will you need to be successful?

• Experience in supporting local/regional/global regulatory affairs projects as needed and expand knowledge in local regulatory affairs management.
• Knowledge of the preparation and submission for new product registrations, line extensions, variations, renewals, and tender documents for GCC as required.
• Experience in the management of post-market activities to ensure regulatory compliance.
• Experience with managing and actioning regulatory intelligence with full gap assessment and impact on the business on a timely manner.
• Reviewing and approval of promotional material and marketing/med ed activities inline with the applicable laws and SN polices/procedure.

Successful candidates would need the following:

• Two years’ experience in quality management, preferably in medical devices
• Proven track record to consistently achieve regulatory and quality requirements.

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, Diversity 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/)
• 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 Insurance and an Employee Wellness Programme and much more.
• Flexibility: Hybrid Working Model (For most professional roles).
• Training: Hands-On, Team-Customised, Mentorship.

Stay connected and receive alerts for jobs like this by joining ourtalent community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. 

Check ourGlassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer.