Remote Clinical Lead — Strategy, PMCF & HFE

Walker Cole International; United States; Remote; GBP 90,000 - 130,000; Full time

Job summary

Walker Cole International is recruiting for a Clinical Lead to own clinical strategy and deliver clinical, PMCF and HFE studies for a leading medical device manufacturer. You will lead a team of clinical specialists and collaborate with cross-functional teams to ensure robust clinical evidence supports product claims and regulatory submissions.

The role requires an experienced clinical affairs professional with strong leadership, budget management, and regulatory writing skills.

Qualifications

• A degree in a life science, clinical or healthcare discipline, with significant clinical affairs or clinical research experience in medical devices.
• Proven experience authoring and approving CERs and PMCF plans and reports under EU MDR.
• Experience leading clinical and/or HFE studies end to end, including budgets, vendors and CROs.
• Working knowledge of ISO 13485, ISO 14155, ISO 14971, FDA requirements, MDD and MDR.

Responsibilities

• Set clinical strategy for assigned products and portfolios, acting as the clinical subject-matter authority.
• Lead, mentor and develop clinical specialists to ensure quality of deliverables.
• Own delivery of clinical, PMCF and HFE studies to budget, scope and schedule.
• Prepare and approve CERs, clinical evaluation plans and PMCF plans and reports under EU MDR 2017/745.
• Manage clinical budget and external vendor relationships (CROs, sites).
• Define clinical requirements and options for regulatory submission pathways.
• Provide clinical guidance on product claims, labeling and design changes.

Skills

Clinical leadership

People management

Budget management

Regulatory knowledge

Technical writing

Project management

Regulatory submissions

Communication

Education

Life science/healthcare degree

Job description

Walker Cole International is recruiting for a Clinical Lead to own clinical strategy and deliver clinical, PMCF and HFE studies for a leading medical device manufacturer. You will lead a team of clinical specialists and collaborate with cross-functional teams to ensure robust clinical evidence supports product claims and regulatory submissions.

The role requires an experienced clinical affairs professional with strong leadership, budget management, and regulatory writing skills.