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 Regulatory Affairs Manager to support the team in developing innovative medical devices. Working closely with our Innovation, Development and Industrialisation teams, you will be responsible for providing training and education to R&D personnel and ensuring overall Regulatory compliance. 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 ensuring regulatory compliance and proactively reviewing and assessing regulatory changes. You must consider the impact that Regulatory changes may have on identified areas of business both within Eakin R&D and within the Eakin Healthcare Group. You will also support the development and implementation of a global regulatory strategy for 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 regulatory representative
- Represent Eakin R&D on matters of Regulatory Affairs, providing guidance and ensuring adherence
- Liaise with QA/RA functions within the Eakin Healthcare Group and provide Regulatory support as required
- Develop and implement a Global regulatory product development strategy
- Remain up to date with impending changes and developments regarding regulatory compliance as well as evolving best practice in compliance control
- Inform the business of the impact of regulatory changes and ensure timely compliance
- Provide guidance and support regarding product registrations in all countries where Eakin Healthcare market product
- Manage technical documentation in accordance with relevant Regulations
- Provide support to enhance understanding of ISO10993, identify possible gaps and guide testing when required
- Support the clinical function by reviewing design of clinical efficacy and safety studies for newly designed products
Your role as Regulatory Affairs Manager will cover a diverse range of activities but will have focus on ensuring Regulatory compliance of all products developed within Eakin R&D. Specifically, you will be expected to:
- Ensure understanding of relevant Medical Device Regulations within the R&D team
- Ensure overall regulatory compliance within Eakin R&D
- Inform relevant stakeholders on the impact of any regulatory changes and ensure continued compliance
- Support required post market design changes of products marketed by Eakin Healthcare Group
- Review clinical development plans for assigned programs in portfolio
- Ensure safety and performance requirements of all new products are met
- Adopt a continuous improvement approach by proactively seeking out development opportunities to ensure that Eakin R&D has the right regulatory skills to deliver business needs.
- Work closely with the innovation team to assess the impact of new concepts on regulatory environment
- Build relationships with external agencies such as notified bodies.
- Support other departments within the Eakin Group, including Technical Support, Quality, Sales and Marketing with advice and guidance on Regulatory compliance.
- 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)
- Minimum of 2 years’ Regulatory Affairs experience within Medical Device Industry
- Experience in MDD/MDR, ISO10993, ISO13485 and ISO14971
- Ability to demonstrate regulatory knowledge in Class I and Class IIa of medical devices
- Experience in conducting risk assessments
- Experience in conducting internal and external audits
- Experience of dealing directly with Notified bodies and Competent Authorities
- Degree level qualification (or equivalent) in Science or Engineering Discipline
- Working knowledge of Class IIb and Class III of medical devices
- Experience in ISO14001
- Experience generating, maintaining, and updating technical files to support submissions in Europe, US and preferably other territories
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 aspects of regulatory compliance and to take on ‘ad-hoc’ projects as the business requires.
KEY WORKING RELATIONSHIPS
- Working within the R&D team to ensure regulatory compliance
- Working alongside QA/RA functions across Eakin Healthcare Group to encourage shared learnings, consistency, and opportunities for improvement
- Group wide manufacturing to support on-going post market compliance
- Working alongside the Commercial team(s) to understand the commercial implications of regulatory requirements
- Test houses
- Notified bodies
- Competent authorities
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.