Smith+Nephew
Medical Devices
SeniorSpecialist,EvidenceEvaluation
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“Senior Specialist, Evidence Evaluation at Smith+Nephew. Skills: Evidence Evaluation, Clinical Data, Regulatory Compliance. Bring together scientific expertise. Create robust clinical evidence documentation”
Industry & Context.
What They're Looking For.
Must Have
Experience in medical writing, Synthesize clinical evidence, Understanding of clinical evaluation processes, Literature review methodologies, Benefit risk assessment, Act as subject matter expert, Engage with cross functional teams, Support regulatory interactions, Support audits, Support submissions, Proactive and organised approach, Manage complex documentation, Manage deadlines, Manage priorities independently, Work as part of a team
Nice to Have
EU MDR knowledge, Related guidance knowledge
What You'll Do.
Bring together scientific expertise
Create robust clinical evidence documentation
Underpin CE registration
Immerse in clinical data
Immerse in literature
Immerse in post market insights
Translate complex information
Demonstrate product safety
Demonstrate product performance
Act as trusted subject matter expert
Support strategic business decisions
Determine product placement
Determine product evolution
How You'll Work.
Team & Collaboration
Cross functional partners
Full Job Description
**Life. Unlimited.** At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about turning clinical evidence into meaningful impact? This is an opportunity to play a critical role in ensuring innovative medical devices continue to meet the highest standards of safety, performance and regulatory compliance. As a Senior Specialist in Evidence Evaluation, you will work at the heart of clinical and regulatory decision making, shaping how our products are supported, sustained and brought to market across Europe and beyond. ### What will you be doing? In this role, you will bring together scientific expertise, medical writing and regulatory understanding to create robust clinical evidence documentation that underpins the continued CE registration of Smith+Nephew products. You will immerse yourself in clinical data, literature and post market insights, translating complex information into clear, high quality documentation that demonstrates product safety and performance. Working closely with cross functional partners, you will act as a trusted subject matter expert, supporting audits, submissions and strategic business decisions that determine whether products can be placed on the market and how they evolve over time. ### What will you need to be successful? Success in this role comes from combining technical depth with clarity of thinking and collaboration. You will bring: * Strong experience in medical or scientific writing, with the ability to critically appraise and synthesise clinical evidence in line with EU MDR and other related guidance * A solid understanding of clinical evaluation processes, literature review methodologies and benefit risk assessment within medical devices or a closely related regulated environment * The confidence to act as a subject matter expert, engaging with cross functional teams and supporting regulatory interactions, audits and submissions * A proactive and organised approach, with the abi
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