Clinical Project Manager TLNT1_NI

At Eakin Healthcare, care is at the heart of everything we do. We are a family-owned global medical device company driven by a simple vision: Where Care Leads, Hope Follows. For more than 50 years, we've been developing innovative healthcare solutions that make a meaningful difference to the lives of patients around the world. Today, our team of over 700 colleagues operates across three UK manufacturing sites, 12 international sales and distribution centres, and exports to more than 60 countries worldwide. From market-leading Ostomy and Respiratory therapies to our trusted Respond home delivery service, we're committed to improving lives through innovation, quality and exceptional care. We don't just care for the people who use our products and services, we care for our colleagues too. That's why we're proud to be recognised as a Great Place to Work, creating an environment where people can thrive, grow and make a real impact. If you're looking for a career with purpose, where your work matters and your contribution is valued, we'd love to hear from you. WHY JOIN US? We're good at what we do - come and join us and you can benefit from: Blended Working Bonus 25 days holiday plus bank holidays (rising to 28) Option to buy holiday days Wellbeing Programme Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE Reporting to the Director of QARA and Clinical, this is an exciting opportunity to play an important role within Eakin Healthcare. Expansion and diversification of our product portfolio necessitates a dedicated Clinical Project Manager to support the team in developing innovative medical devices. Working closely with our Research and development, and Commercial teams, you will be responsible for managing multiple projects to validate the clinical efficacy of Eakin Healthcare products. This will be a site-based role in Comber. Occasional UK travel may be required. KEY RESPONSIBILITES Clinical/User Study Design and Delivery Design, manage, and report on multiple types of clinical and product evaluation studies across international markets Design and manage usability/human factors studies across development stages, including engaging with end users when required Support clinical investigation (where appropriate) of devices within the Eakin Healthcare Group Design, management, and reporting of post-market surveillance activities to assess the device risk profile and support commercial teams to develop areas of product differentiation (e.g., post-market user evaluations) Develop and manage user database for future user trial recruitment New product development Work closely with the R&D and commercial teams to assess the potential clinical and user requirements of new concepts Work closely with the R&D and commercial teams to ensure all aspects of the user and clinical pathways are considered during development Support development of user requirements for new products Manage the usability process for all devices developed by Eakin R&D Plan and manage validation activities related to the user experience and clinical outcomes Ensure rigorous clinical and user appraisal of all devices developed by Eakin R&D e.g. literature searches, clinical evaluation Regulatory compliance and clinical documentation Manage clinical documentation in accordance with relevant regulations Remain up to date with impending changes and developments regarding clinical-regulatory compliance Provide support to enhance internal understanding of ISO14155 Collaboration and Stakeholder Engagement Collaborate with QA/RA functions within the Eakin Healthcare Group and provide clinical support as required Build relationships with external agencies to support clinical activities in all countries where Eakin Healthcare products are marketed Support other departments within the Eakin Group, including Technical Support, Quality, Sales and Marketing, with advice and guidance on clinical efficacy Provide clinical guidance and support to all countries where Eakin Healthcare markets product Other To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy To adhere to the company's Quality policy and Environmental policy To undertake other duties as may be reasonably required WHAT WE'RE LOOKING FOR Essential Degree level qualification (or equivalent) Experience within Medical Device Industry Desirable Experience in questionnaire design/focus group facilitation/user interviews to collect user feedback Ability to demonstrate regulatory knowledge of medical devices Experience in conducting user evaluations and/or user research activities. Experience in conducting human factors studies Fluency in additional European language KEY WORKING RELATIONSHIPS Internal Working with Operations and the R&D team to support clinical activities and provide advice and support to peers Collaborating with Commercial functions across Eakin Healthcare Group to support gathering of clinical data for market launch and on-going device marketing activities Group wide QA/RA functions to provide clinical support for continuous improvement External Healthcare professionals End-users Regulatory bodies Research agencies ADDITIONAL INFORMATION Ability/willingness to develop within the role Ability/willingness to attend training courses in relation to the role and the needs of the department Ability/willingness to travel to other Eakin Group sites as needed Blended working between home and office available COMPETENCIES Customer Focus Building strong customer relationships and delivering customer-centric solutions. Global Perspective Taking a broad view when approaching issues, using a global lens. Optimizes Work Processes Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement. Builds Networks Effectively building formal and informal relationship networks inside and outside the organization. Values Differences Recognising the value that different perspectives and cultures bring to an organisation. Communicates Effectively Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences. Instills Trust Gaining the confidence and trust of others through honesty, integrity and authenticity. Nimble Learning Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder. The closing date for applications is: Wednesday 12th August 2026 If we receive a high volume of applications, we may close this role earlier than planned. 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TLNT1_NI