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. Regulatory Affairs plays a vital role in this process, ensuring our products remain compliant with market and patient needs. Our products are in over 100 countries, and supporting this global reach requires significant effort.Role Overview Join our Regulatory Operations team in a role that redefines the conventional. This position combines strategy, systems, and data-driven transformation to create smarter, faster, and more compliant regulatory processes. You will lead improvement projects, own systems that support our global regulatory function, and shape our operational evolution.Key ResponsibilitiesLead process improvement initiatives within Regulatory Affairs.Identify inefficiencies and develop strategies for optimization.Manage project lifecycles, including scope, timelines, and risk mitigation.Facilitate cross-functional collaboration aligned with business objectives.Own and enhance regulatory systems, including defining requirements and user acceptance testing.Monitor performance metrics for continuous improvement.Maintain compliant documentation such as SOPs, work instructions, and training materials.Provide training and support on systems and processes.Ensure compliance with applicable standards and regulations.Stay updated on industry trends and regulatory changes.Qualifications for Success A bachelor’s degree in Regulatory Affairs, Engineering, or a related field, with relevant regulatory experience. Strong understanding of regulatory requirements, industry standards, and QMS (including GMP). Proven experience managing process improvements, and proficiency with data tools like Excel or Tableau.Our Commitment to YouInclusion, Diversity, and Equity: We celebrate diversity and promote an inclusive environment. Learn more about our Employee Inclusion Groups on our website.Benefits: Competitive bonuses, pension schemes, share options, and more.Work/Life Balance: Flexible vacations, paid holidays, and volunteering hours.Wellbeing: Health plans, income protection, life insurance, and more.Flexibility: Hybrid working models for most roles.Training & Development: Customized mentorship and hands-on training.Perks: Discounts on gyms, bicycles, cars, and other employee benefits.Stay connected by joining our talent community, follow us on LinkedIn, and visit our Glassdoor page to learn more about our culture and opportunities.#J-18808-Ljbffr

Created: 2025-07-25