Sr. Manager, Evidence Evaluation (US-Remote)

Life Unlimited. At Smith+Nephew 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 Smith+Nephew' s Orthopedics, Trauma and Extremities, and Robotics portfolio.

What will you be doing?

TheSr. Manager, Evidence Evaluationplays 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 Smith+Nephew.

TheSenior Manager, Evidence Evaluationis responsible for leading the development of high-quality clinical documentation to support the continued CE marking of Smith+Nephew 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: <10%

The anticipated compensation range for this position is $130,000.00 - $170,000.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).

Life at Smith+Nephew: At Smith+Nephew, we care for one another professionally and personally. Find out more about inclusion, diversity and equity, flexibility, and wellbeing at work.

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.