Remote Senior Manager, Clinical Evaluation

elemed; United Kingdom; Remote; GBP 90,000 - 130,000; Full time

Job summary

elemed is seeking a senior leader to direct a clinical evaluation team across multiple business units. You will provide senior scientific oversight of CEPs/CEPRs, ensure EU MDR compliance, and lead complex evaluations including new product introductions and significant changes.

You’ll work with Regulatory, Medical Affairs, Quality, and external partners, while helping shape the AI-enabled tooling within the function.

Qualifications

• Advanced degree in life science or clinical discipline.
• Proven experience authoring and reviewing Clinical Evaluation Reports under EU MDR.
• Experience in medical device industry, surgical devices, ophthalmology advantageous.

Responsibilities

• Lead and develop a team of clinical evaluation professionals across four business units.
• Provide senior scientific oversight and review CEPs and CPRs.
• Ensure alignment with EU MDR 2017/745 and MDCG guidance.
• Act as lead author or senior reviewer on complex evaluations.
• Set approach to systematic literature review and evidence synthesis.
• Collaborate with Regulatory Affairs, Medical Affairs, Quality and post-market surveillance teams.
• Lead development and revision of SOPs and work instructions.
• Collaborate with AI programmes to build bespoke tooling for efficiencies.
• Manage relationships with external medical writing and literature review partners.
• Monitor EU MDR changes and disseminate impact across the function.

Education

MSc in Life Science

PhD in Life Science

Job description

elemed is seeking a senior leader to direct a clinical evaluation team across multiple business units. You will provide senior scientific oversight of CEPs/CEPRs, ensure EU MDR compliance, and lead complex evaluations including new product introductions and significant changes.

You’ll work with Regulatory, Medical Affairs, Quality, and external partners, while helping shape the AI-enabled tooling within the function.