ABOUT THE ROLE
Reporting to the Head of Clinical and Regulatory Affairs this is an exciting opportunity to play an important role in a growing R&D team. 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 Innovation, Development and Industrialisation 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 Cambridge area will also be considered.
Working within Eakin R&D, you will be responsible for designing, managing, and reporting on multiple types of clinical studies at various stages of the product lifecycle. You will also support the Head of Clinical and Regulatory Affairs to develop and implement a clinical strategy to support product development and approval.
As part of a multidisciplinary, skilled team you will contribute to the development of new Ostomy, Wound and Surgical devices in conjunction with helping the business to appraise potential opportunities for diversification. You will be involved at all stages of product development from strategy through to manufacture-ready products, in parallel with Eakin R&D’s New Product Introduction (NPI) strategy. Through this you will:
- Participate in cross functional product development teams as the clinical representative
- Collaborate with QA/RA functions within the Eakin Healthcare Group and provide clinical support as required
- Support development and implementation of a clinical product development strategy
- Remain up to date with impending changes and developments regarding clinical-regulatory compliance
- Inform the business of the impact of regulatory changes and ensure timely compliance
- Provide clinical guidance and support to all countries where Eakin Healthcare market product
- Manage clinical documentation in accordance with relevant Regulations
- Provide support to enhance internal understanding of ISO14155
Your role as Clinical Project Manager will cover a diverse range of activities but will have focus on ensuring safety and clinical efficacy of all products developed within Eakin R&D. Specifically, you will be expected to:
- Ensure rigorous clinical appraisal of all devices developed by Eakin R&D
- Improve internal knowledge of clinical validation activities
- Design and manage human factors studies
- 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
- Work closely with the innovation team to assess the potential clinical requirements of new concepts
- Delivery of technical input to Regulatory Affairs labelling activities
- 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.
- 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.
- Be responsible for your own health and safety and that of your colleagues, in accordance with the company’s Health and Safety policy.
- Degree level qualification (or equivalent)
- Experience within Medical Device Industry either in product design or clinical validation
- Experience in MDD/MDR, ISO13485 and ISO14971
- Ability to demonstrate regulatory knowledge in Class I and Class IIa of medical devices
- Experience in conducting clinical investigations
- Working knowledge of Class IIb and Class III of medical devices
- Experience in conducting human factors studies
- Provide evidence of conducting clinical investigations in EU and US
- Working knowledge of ISO10993
- Publication of papers in peer reviewed Journals
- Experience of developing an International patient database to support clinical studies
- Fluency in additional European language
The successful candidate
- Will be able to work in a multi-functional, multi-disciplinary team and to build relationships with peers.
- Will be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
- Will have excellent time management skills and effectively plan, resource, and execute multiple projects simultaneously
- Will be willing to travel across Eakin R&D facilities i.e. Comber, Cardiff and Cambridge with opportunities for additional travel, as required by your role.
- Will be prepared to take a hands-on approach to all clinical activities and to take on ‘ad-hoc’ projects as the business requires.
KEY WORKING RELATIONSHIPS
- Working within the R&D 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
- Healthcare professionals
- Regulatory bodies
- Research agencies
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Supporting Others – Enjoys supporting other people and is prone to getting involved and trying to help them when they have problems. Is comfortable to contribute to joint endeavours and enjoys team work. Is willing to let other people depend on them.