ABOUT THE ROLE
Reporting to the Eakin R&D (ERD) Head of Clinical & Regulatory Affairs this is an exciting opportunity to play a key role in managing a growing Regulatory team. Working closely with our Commercial, Quality and Production teams, you will be responsible for ensuring regulatory compliance of existing and new products. This role will be based at our Coleraine site.
- Represent Armstrong Medical (AML) on matters of Regulatory Affairs, providing guidance to colleagues and ensuring adherence in all relevant jurisdictions
- Liaise closely with the AML Quality Assurance function and provide Regulatory support as required
- 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 AML products are sold
- Manage technical documentation in accordance with relevant Regulations
- Provide support to enhance understanding of relevant product and regulatory standards
- Participate in cross functional product development teams as the regulatory representative
- Develop and implement a Global regulatory product development strategy
- Build and manage relationships with external agencies such as competent authorities and notified bodies
- Lead the company’s activities in relation to compliance with the EU Medical Device Regulation (MDR)
- Act as the company’s Person Responsible for Regulatory Compliance (PRRC) in accordance with the MDR
- Prepared to take a hands-on approach to all aspects of regulatory compliance and to take on ‘ad-hoc’ projects as the business requires.
- 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
- Degree level qualification (or equivalent)
- Previous Regulatory Affairs experience within Medical Device or IVD Industry
- Experience in MDD/MDR or IVD/IVDR, ISO13485 and ISO14971
- Ability to demonstrate experience in defining and managing regulatory requirements for a variety of medical devices
- Experience in conducting product risk assessments
- Experience of dealing with Notified bodies and Competent Authorities and other external stakeholders
- Ability to work in a multi-functional, multi-disciplinary team and to build relationships with peers.
- Methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
- Excellent time management skills to effectively plan, resource, and execute multiple projects simultaneously
- Degree level qualification (or equivalent) in Science or Engineering Discipline
- Experience generating, maintaining, and updating technical files to support submissions in Europe, US and other territories
- Experience in worldwide device registrations
- Experience in conducting internal and external audits
KEY WORKING RELATIONSHIPS
- Working within the Regulatory team at AML 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
- Ability/willingness to travel to other Eakin Healthcare Group sites as required
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 teamwork. Is willing to let other people depend on them.
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Resilience – Can work under pressure, remains calm, thinks clearly, and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and does not dwell on past events