AtEakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. Weve been recognised as a Great Place to Work! And were proud to be named among theBest Workplaces in HealthcareandBest Workplaces for Women. At Eakin Healthcare, were united by one mission:working together to improve lives- just like weve been doing for over five decades. WHY JOIN US? Were 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 Head of Clinical and Regulatory Affairs, 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. Ideally this role will be based at our Comber site, however applicants based in the Cardiff or Coleraine area will also be considered. KEY RESPONSIBILITES Clinical/User Study Design and Delivery Design, manage, and report on multiple types of clinical and user studies across international markets Design and manage usability/human factors studies across development stages, including engaging with end users when required Complete activities to support clinical investigation (where appropriate) of devices within the Eakin Healthcare Group Design and manage 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) Recruit users to grow an international user database for future user trial recruitment New product development Work closely with the RandD and commercial teams to assess the potential clinical and user requirements of new concepts Work closely with the RandD and commercial teams to ensure all aspects of the user and clinical pathways are considered during development Inform user requirements for development projects Manage the usability process for all devices developed by Eakin RandD Complete validation activities related to the user experience and clinical outcomes Ensure rigorous clinical and user appraisal of all devices developed by Eakin RandD (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 companys 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 companys Health and Safety policy. To adhere to the companys Quality policy and Environmental policy. To undertake other duties as may be reasonably required. WHAT WERE LOOKING FOR Essential Degree level qualification (or equivalent) Experience in a clinical setting (industry or public sector) Experience in questionnaire design/focus group facilitation to collect user feedback in a healthcare setting Desirable Experience within Medical Device Industry either in product design or clinical validation Ability to demonstrate regulatory knowledge of medical devices Experience in conducting user trials and/or user research activities. Experience in conducting human factors studies Provide evidence of conducting clinical investigations in EU and US Experience of developing an international patient database to support clinical studies Fluency in additional European language. KEY WORKING RELATIONSHIPS Internal Working with Operations and the RandD team to manage 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 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. Skills: clinical medical device regulatory knowledge user trials user feedback human factors