Sr. Manager Evidence Evaluation

Smith+Nephew; United Kingdom; On-site; GBP 75,000 - 90,000; Full time

Job summary

A leading medical technology company in the UK is seeking a Senior Manager, Evidence Evaluation. The role is responsible for leading the development of high-quality clinical documentation and ensuring regulatory compliance. Candidates should have a strong background in medical writing, and a minimum of 7 years' experience in the medical devices sector. The position provides leadership to a dedicated team and requires exceptional skills in communicating complex scientific concepts.

Qualifications

• Minimum of 7 years' industry experience or 10 years’ combined academic and industry experience.
• Experience in medical devices or pharmaceutical organizations is required.
• Proven experience in communicating scientific documents.

Responsibilities

• Oversee the creation and review of regulatory documents ensuring audit readiness.
• Provide leadership and performance management to the Evidence Evaluation team.
• Maintain expert knowledge of regulatory guidance and represent during audits.

Skills

Medical writing expertise

Clinical knowledge

Regulatory insight

Data analysis

Leadership

Education

Bachelor's degree in a relevant discipline

Master's degree or PhD

Job description

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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.