Senior Clinical Evaluation & Post-market Surveillance Specialist

Job Summary

Are you ready to make a difference in the world of medical devices? As a Senior Clinical Evaluation and Post-market Surveillance Specialist, you’ll lead the clinical evidence strategy for cutting-edge medical devices, ensuring their safety, performance, and compliance on a global scale. This role requires expertise in clinical evaluation, post-market surveillance, and regulatory compliance. You’ll be instrumental in shaping long-term strategies, engaging with regulatory bodies, and driving innovation in patient safety.

Key Responsibilities

Clinical Evaluation

• Lead the planning, creation, and maintenance of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Plans (PMCFPs), and related documentation.
• Design and implement clinical evidence strategies, considering global regulatory requirements, device intended use, and risk classification.
• Conduct systematic literature reviews and in-depth analysis of clinical and post-market data to validate safety and performance.
• Develop and update State of the Art (SoTA) analyses to reflect medical and scientific advancements.
• Collaborate with Regulatory Affairs, Device Development, and other teams to ensure alignment on clinical evidence requirements for successful regulatory submissions.
• Act as the Clinical Evaluation Project Manager, driving alignment across adjacent processes, including marketing, regulatory, and clinical research strategies.

Post-Market Surveillance (PMS)

• Manage and create PMS Reports and Periodic Safety Update Reports (PSURs) for assigned devices.
• Support vigilance activities, including updates to Risk Management Files and product labelling based on PMS data.
• Act as the SME (Subject Matter Expert) in vigilance and PMS activities, representing expertise during internal and external audits.
• Contribute to the design of PMCF activities (e.g., studies, surveys, registries) in collaboration with the clinical research team.

Cross-functional Contributions

• Support preparation of peer-reviewed publications, white papers, clinical summaries, and presentations.
• Provide training and mentorship to new starters and team members on clinical evaluation and PMS processes.
• Develop and maintain SOPs and processes for Clinical Evaluation and PMS activities.
• Monitor and analyse regulatory trends to ensure the organisation remains at the forefront of compliance and innovation.

About You

You are a proactive, self-motivated and detail-oriented professional with a passion for clinical excellence and patient safety. You thrive in a collaborative environment, enjoy solving complex problems, and have a proven ability to manage projects and mentor others.

Qualifications:

• Education: BSc in a related field is required. A higher degree (MSc, PhD, MD, RN, BSN, or equivalent) is highly advantageous.

• Experience:
• Experience in CE marked medical devices is a must
• Minimum 5 years of documented industry experience in Clinical Evaluation, Risk Management, or Post-Market Safety for medical devices.
• 2-5 years of experience in Scientific/Medical Writing or relevant academic/clinical research.
• Expertise in clinical regulations for major global markets, including US and EU.
• Strong track record in managing complex projects and contributing to innovation within clinical or regulatory fields.

• Skills:
• Excellent written and verbal communication skills, including the ability to prepare technical regulatory submissions.
• Proficiency in MS Office and IT systems.
• Demonstrated ability to analyse clinical, regulatory, and scientific data critically.
• Proven ability to mentor team members and foster a culture of continuous improvement.

What We Offer

• A dynamic and collaborative work environment where innovation and quality are at the core of everything we do.
• Opportunities to work on meaningful projects that directly impact patient outcomes.
• Competitive salary and benefits package.
• Hybrid working model, offering flexibility and a healthy work-life balance.

If you’re ready to take on this challenging and rewarding role, we’d love to hear from you. Apply today and join a team dedicated to making a difference in healthcare.

How to Apply: Please submit your CV and a cover letter outlining your suitability for the role.