Smith+Nephew is hiring a Sr. Manager, Evidence Evaluation (US-Remote)

Smith+Nephew is hiring a Sr. Manager, Evidence Evaluation to play a critical role in ensuring regulatory compliance through the development of complex clinical documentation for our Orthopedics, Trauma and Extremities, and Robotics portfolio. This position requires a unique combination of medical writing expertise, clinical and device knowledge, scientific expertise, and regulatory insight to produce documentation that meets stringent standards.

What You'll Do

• Oversee the creation and review of key regulatory documents (e.g., CEP, CER, PMCF ER, SSCP), ensuring scientific rigor and audit readiness.
• Mentor and manage the Evidence Evaluation team, providing leadership, coaching, and performance management.
• Maintain expert knowledge of EU MDR, MEDDEV, and MDCG guidance; represent the organization during audits and regulatory interactions.
• Critically appraise literature and internal/external data sources to assess benefit-risk profiles and support product safety narratives.
• Provide cross-functional support across clinical, scientific, and regulatory domains, including input on new product development, risk, and post-market activities.
• Make independent, evidence-based decisions on conformity assessments and contribute to strategic planning for new product development.
• Continuously refine internal processes to close compliance gaps, improve efficiency, and uphold regulatory best practices.
• Communicate clinical and scientific insights effectively to diverse audiences, including regulators, healthcare professionals, and internal stakeholders.
• Align team capabilities with business needs through strategic resourcing, recruitment, and development planning.

What We're Looking For

• Bachelor's degree in a relevant discipline as a minimum.
• 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.
• 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.
• Minimum 3 years of supervisory experience.

Nice to Have

• Master's degree or PhD.

Benefits & Compensation

• Compensation range: $130,000.00 - $170,000.00 USD annually.
• 401k Matching Program and 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• PTO, Paid Holidays, Flex Holidays, and a Paid Community Service Day
• Medical, Dental, Vision coverage
• Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Hands-On Training and Team-Customized Training
• Mentorship
• Discounts on fitness clubs, travel and more

Work Mode

This is a remote position open to candidates located in the United States.

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.