Regulatory Affairs & Commercial Quality Excellence Manager

Regulatory Affairs & Commercial Quality Excellence Manager Emerging Markets - 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?

At Smith+Nephew, we design and manufacture technology that takes the limits off living. We are seeking a highly experienced Regulatory Affairs & Commercial Quality Excellence Manager to lead regulatory operations and commercial quality excellence activities across our Emerging Markets region. This strategic leadership role is responsible for driving regulatory compliance, operational excellence, quality system effectiveness, and cross-functional process improvements while supporting business growth and ensuring adherence to evolving regulatory requirements. The successful candidate will work closely with regional and global stakeholders to deliver best-in-class regulatory and quality outcomes across a diverse and dynamic market landscape.

What will you need to be successful?

Regulatory Affairs Operational Excellence

• Develop and implement regulatory operational strategies that support business and compliance objectives across Emerging Markets.
• Lead and oversee regulatory submission activities, ensuring timely and compliant submissions to regulatory authorities.
• Partner with global and regional teams to drive alignment of regulatory processes, standards, and lifecycle management activities.
• Act as a subject matter expert for regulatory systems, applications, databases, and process optimisation initiatives.
• Monitor evolving regulatory requirements and ensure continued compliance across all markets.
• Drive submission planning, tracking, and execution to minimise business disruption and support market access objectives.
• Support and oversee labelling compliance initiatives while optimising shared pack strategies across markets.

Quality Excellence Leadership

• Champion a culture of continuous improvement and operational excellence across the region.
• Develop and maintain quality excellence strategies, inspection readiness programmes, and risk management frameworks.
• Monitor Quality Management System (QMS) performance and identify opportunities to improve efficiency, compliance, and effectiveness.
• Lead cross-functional quality improvement and compliance projects.
• Conduct gap assessments against applicable regulations, standards, and company policies, ensuring corrective actions are implemented effectively.

Regulatory Quality Control & Compliance

• Establish and maintain quality control processes for regulatory submissions.
• Ensure submissions meet local and international regulatory requirements and achieve first-pass acceptance whenever possible.
• Support system audits and regulatory inspections.
• Oversee compliance of submission-related processes and systems in line with company SOPs and quality standards.

Leadership & Stakeholder Management

• Provide leadership, guidance, and coaching to regulatory teams and distributor partners across the region.
• Support talent development, succession planning, and performance management initiatives.
• Foster strong partnerships with internal stakeholders, regional teams, global functions, and external partners.
• Drive alignment, consistency, and efficiency across clusters and markets.

Successful candidates would need the following:

• Bachelor's degree in Pharmacy, Quality Management, Management Information Systems, Life Sciences, or a related discipline.
• Minimum 7 years' experience within Regulatory Affairs and/or Quality Assurance, preferably across both disciplines.
• Minimum 3–5 years' experience within the medical device industry.
• Strong knowledge of regulatory requirements and pathways across Emerging Markets.
• Experience developing, implementing, and maintaining Quality Management Systems.
• Experience authoring and managing SOPs, procedures, and compliance documentation.
• Demonstrated success leading regional projects and cross-functional teams.
• Medical device regulatory experience across multiple Emerging Markets countries.
• Experience with Lean, Six Sigma, or process excellence methodologies.
• Auditing experience.
• Knowledge of warehousing, distribution, and supply chain quality processes.
• Experience supporting both direct and distributor business models.

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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