Senior Director, Regulatory Affairs & Commercial Quality, Emerging Markets

Senior Director, Regulatory & Commercial Quality, Emerging Markets

Locations: UK, Europe or APAC

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

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 18,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Role Overview

This Regulatory Affairs (RA) Position is responsible for overseeing the tactical and strategic alignment of regional RA & Commercial Quality functions in the Emerging Markets (South Africa, Central Eastern Europe, Gulf Corporation Council (GCC) countries, Turkey, India and ASEAN regions). This role is also manages the execution of in-country support RA & Commercial Quality support to the in-country commercial teams. The role is responsible for enabling market access and market continuity by working cross functionally to meet market needs. The role is also responsible for ensuring the quality delivery of products and services to Smith & Nephew’s customers and patients.

This role will report to the VP of Regional Regulatory & Commercial Quality and serve as a member of the Emerging Markets leadership team

What will you be doing?

• Provide leadership and strategic direction to optimize regulatory approval of new business opportunities and ensure compliance of existing products with regulatory requirements
• Enable support for market continuity for products through licence renewal with consideration for return on inventment.
• External collaboration with government bodies, creating and maintaining strong relationships with internal and external stakeholders.
• Provide strategic advice on regulatory and quality aspects of market expansion.
• Ensure business compliance to in-country regulatory requirements and Smith & Nephew policies and procedures.
• Team management and development
• Champion and oversee Company’s quality management systems and policies

What will you need to be successful?

• Bachelor and above in Biomedical, Engineering, or other medical related fields.
• 10 years or more related industry (e.g. life science) experience preferred
• English Language, strategic thinking, organization and planning, effective negotiation and influencing skills, strong leadership and team development and stakeholder management, Up to date and comprehensive knowledge of the global regulatory environment and ability to translate them into actional strategies, established connections with regulators and industry associations preferred.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• 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/)
• Your Future: Generous annual bonus and pension Schemes, Save As You Earn share 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: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
• Flexibility: Hybrid Working Model (For most professional roles).
• Training: Hands-On, Team-Customised, Mentorship.
• Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.

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