Life Unlimited. At SmithNephew we design and manufacture technology that takes the limits off living. Are you ready to drive impact at the intersection of science, strategy, and healthcare innovation ? We're on the hunt for a Senior Manager, Evidence Evaluation to join our high-performing team and help us shape the future of data-driven decision-making in healthcare. This role is accountable for supporting products within SmithNephew’ s Orthopedics, Trauma and Extremities, and Robotics portfolio. What will you be doing ? The Sr. Manager, Evidence Evaluation plays a critical role in ensuring regulatory compliance through the development of complex clinical documentation. This position requires a unique combination of medical writing expertise, clinical and device knowledge, scientific expertise, and regulatory insight. These qualifications are essential for producing documentation that meets stringent regulatory standards and withstands audit scrutiny. The role demands a deep understanding of how clinical data supports device safety and performance, as well as how various elements of the Quality Management System interconnect. Applying this knowledge effectively ensures regulatory alignment and overall compliance within SmithNephew. The Senior Manager, Evidence Evaluation is responsible for leading the development of high-quality clinical documentation to support the continued CE marking of SmithNephew products. This includes overseeing the creation of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Clinical Follow-up Evaluation Reports (PMCF ERs), Summaries of Safety and Clinical Performance (SSCPs), evidence gap analyses, and benefit-risk assessments in alignment with applicable regulatory standards. Oversee Clinical Documentation Development Manage the creation and review of key regulatory documents (e.g., CEP, CER, PMCF ER, SSCP), ensuring scientific rigor and audit readiness. Mentor and Manage Evidence Evaluation Team Provide leadership, coaching, and performance management to a team of professionals, fostering growth and ensuring high-quality deliverables. Ensure Regulatory Compliance and Readiness Maintain expert knowledge of EU MDR, MEDDEV, and MDCG guidance; represent the organization during audits and regulatory interactions. Evaluate and Synthesize Clinical Data Critically appraise literature and internal/external data sources to assess benefit-risk profiles and support product safety narratives. Act as Subject Matter Expert (SME) Provide cross-functional support across clinical, scientific, and regulatory domains, including input on new product development, risk, and post-market activities. Drive Strategic Decision-Making Make independent, evidence-based decisions on conformity assessments and contribute to strategic planning for new product development. Promote Process Excellence and Innovation Continuously refine internal processes to close compliance gaps, improve efficiency, and uphold regulatory best practices. Translate Complex Scientific Concepts Communicate clinical and scientific insights effectively to diverse audiences, including regulators, healthcare professionals, and internal stakeholders. Support Resource Planning and Recruitment Align team capabilities with business needs through strategic resourcing, recruitment, and development planning. What will you need to be successful? Education: Education: Bachelors in a relevant discipline as a minimum. Master's degree or PhD preferred Experience: Minimum of 7 years' industry experience or 10 years’ academic and industry combined. Experience working within a medical devices or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role is required. Proven experience in performing literature reviews, analyzing data sets and communicating the outputs. Experience in writing scientific documents for regulatory or journal submissions Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams. Leadership if any: Minimum 3 years of supervisory experience is required. Travel Requirements: 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. 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-KK1 Stay connected and receive alerts for jobs like this by joining our talent 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 our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at SN. Explore our new website and learn more about our mission, our team, and the opportunities we offer.