Global Clinical Evaluation Manager

Global Clinical Evaluation Manager

We are seeking an experienced and highly motivated Global Clinical Evaluation Manager to lead our Global Clinical Evaluation team and drive excellence across all Clinical Evaluation and Post-Market Surveillance (PMS) activities. This is a pivotal leadership role responsible for ensuring the delivery of critical clinical documentation, supporting regulatory compliance, and providing strategic clinical input across the product lifecycle.

As the Global Clinical Evaluation Manager, you will oversee a team of clinical professionals, manage external vendors, and collaborate with cross-functional stakeholders to ensure clinical evidence, post-market activities, and new product development programmes are supported by robust clinical strategies and compliant processes.

What you’ll do:

Leadership & Team Management

• Lead, develop and manage the Global Clinical Evaluation team.
• Conduct performance reviews, provide coaching and mentoring, and support ongoing professional development.

Clinical Evaluation & Post-Market Surveillance

• Oversee the planning, execution and timely delivery of all PMS schedule deliverables, including:
• Literature Searches and Appraisals
• Post-Market Clinical Follow-Up (PMCF) Plans and Reports
• Clinical Evaluation Plans (CEPs)
• Clinical Evaluation Reports (CERs)
• Summary of Safety and Clinical Performance (SSCP)
• Ensure documentation is delivered on time, to a high standard, and in accordance with regulatory requirements.

Vendor Management

• Provide effective oversight and management of external Clinical Evaluation vendors.
• Establish strong working relationships through training, communication, quality monitoring and issue resolution.

Regulatory & Compliance Support

• Lead responses to Notified Body and Competent Authority requests related to Clinical Affairs.
• Coordinate cross-functional input and ensure responses are accurate, timely and professionally presented.
• Maintain compliance with applicable regulations and standards, including:
• EU MDR 2017/745
• ISO 13485
• FDA 21 CFR Part 820
• Good Manufacturing Practice (GMP)

Clinical Strategy & New Product Development

• Ensure appropriate Clinical Affairs representation across Product Core Teams (PCTs).
• Provide expert guidance regarding:
• Clinical benefit
• Product claims
• Risk-benefit assessments
• Clinical evidence requirements
• Market access strategies
• Ensure robust Clinical Development Plans are established and executed for new product introductions.

Clinical Data Generation & Continuous Improvement

• Oversee clinical data collection activities, including studies, registries and surveys.
• Ensure generated evidence supports regulatory and commercial objectives.
• Drive continuous improvement initiatives and maintain awareness of emerging regulatory requirements and industry best practices.

About You

To be successful in this role, you will bring significant experience in Clinical Evaluation within the medical device industry, combined with strong leadership capabilities and a passion for delivering high-quality, compliant clinical evidence.

Essential Qualifications & Experience

• Advanced scientific degree, MD, Nursing qualification, or BS/BA in a relevant scientific discipline.
• Significant experience within Medical Device Clinical Evaluation.
• Extensive experience analysing, interpreting and communicating clinical data to a variety of internal and external stakeholders.
• Strong working knowledge of European Medical Device Directive (MDD) and Medical Device Regulation (MDR).
• Substantial experience in Post-Market Clinical Follow-Up (PMCF) and/or Post-Market Surveillance (PMS) activities.
• Demonstrated experience interacting with Notified Bodies and Competent Authorities.
• Previous people leadership and team management experience.

Skills & Attributes

• Exceptional attention to detail with the ability to maintain a strategic, business-focused perspective.
• Strong organisational skills with the ability to manage multiple priorities and deadlines.
• Proven ability to influence, lead and collaborate across cross-functional teams.
• Commitment to quality, compliance and continuous improvement.

Why Join Us?

This is an exciting opportunity to play a key leadership role within a global organisation committed to improving patient outcomes through innovation and clinical excellence. You will have the opportunity to shape clinical evaluation strategy, influence new product development, and lead a talented team in a dynamic and evolving regulatory environment.

• Competitive salary and annual Bonus alongside excellent benefits
• Career development and growth opportunities
• Inclusive and collaborative culture
• Opportunities to make a meaningful impact on patient outcomes

If you are a passionate Clinical Affairs leader looking for your next challenge, we would love to hear from you.

Apply today and help shape the future of clinical excellence.