Regulatory Affairs Operations Specialist

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. Long before any of this is possible, we have to go through many steps that will validate and verify our products. Regulatory Affairs plays a vital part in the process! Ensuring our products are and remain compliant to the needs of the market, and needs of patients. Our products are in 100 countries globally, and supporting this takes a huge effort.

Imagine a role where you\’re not just part of the process, you redefine it. At the heart of our innovative medical devices\’ company, we\’re looking for a trailblazer to join our Regulatory Operations team. This isn\’t your typical regulatory role. This is where strategy meets systems, and data drives transformation.

You\’ll be the architect of smarter, faster, and more compliant regulatory processes. From leading high-impact improvement projects to owning the systems that power our global regulatory function, you\’ll shape how we operate today, and how we evolve tomorrow. Think data metrics, process expansion, system ownership, and cleansing complexity into clarity.

What Will You Be Doing?

• Lead and deliver process improvement initiatives across the Regulatory Affairs organisation.
• Identify inefficiencies and develop strategies to optimise regulatory processes.
• Manage end-to-end project lifecycles, including scope, timelines, deliverables, and risk mitigation.
• Facilitate cross-functional collaboration and ensure alignment with business objectives.
• Own and enhance regulatory systems, including defining user requirements and conducting user acceptance testing.
• Monitor performance metrics to drive continuous improvement and data-informed decision-making.
• Maintain clear, compliant documentation, including standard operating procedures (SOPs), work instructions, and training materials.
• Provide training and support on new systems, processes, and best practices.
• Ensure regulatory processes comply with local, national, and international standards.
• Stay up to date with industry trends and regulatory changes to support ongoing improvements.

What will you need to be successful?

To be successful in this role, you\’ll ideally hold a bachelor\’s degree in a relevant field such as Regulatory Affairs, Engineering, or a related discipline, along with experience in regulatory affairs.

You\’ll bring a solid understanding of regulatory requirements, industry standards, and quality management systems (QMS), including Good Manufacturing Practices (GMP). Experience with regulatory submissions, change control, and compliance documentation is essential.

You\’ll have a proven track record in managing process improvement projects, you should be comfortable working both independently and collaboratively, and confident using data analysis and reporting tools such as Excel or Tableau to support decision-making and continuous improvement.

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 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.

#LI-hybrid #LI-BM2.

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