Regulatory Intelligence Specialist x5
- Reporting to the Head of Regulatory, you will be responsible for supporting and coordinating Regulatory Intelligence, proactive global monitoring, and surveillance activities of the Medical Device development lifecycle from preclinical through commercialisation
- Taking a lead in delivering the regulatory newsletter content to the organisation, as well as ownership of the content and updates to the Regulatory Intelligence in your designated geographical location
- Supporting internal partners with the collection and distribution of requested regulatory intelligence queries or information. This will include drafting the summary of revisions for updated guidance and regulations documents.
- Performing quality checks of global regulatory requirements and documents for appropriate categorisation, metadata, redundancies, errors, and documents that are out of scope
- Contributing to the development of regulatory intelligence reports or results as it relates to project strategies. This will also include the management of data into systems or tools to enable effective knowledge management of country-level operational intelligence data.
- Supporting the Regulatory team with complex queries, initiatives and deliverables by providing entry and tracking of impact assessment decisions
- Supporting the distribution of key regulatory information to targeted departments and partners, in addition, conducting initial analysis of commenting opportunities
- Assisting with drafting of comments for submission to industry organisations, Health Authorities, and other partners with oversight from the Head of Regulatory Affairs and other relevant team members
- Assisting in developing and refining regulatory intelligence processes and procedures to build efficiencies, and tracking minutes from meetings, and coordinates review meetings
- Experience of ISO14971 Risk Management Systems, IEC62304 Software Development Processes, IEC62366 Human Factors Engineering, ISO14155 Clinical Investigations
- Experience in relevant standards, processes, and systems such as
- The application of risk management ISO 14971
- Software development IEC62304
- Human factors engineering IEC62366
- Electrical medical equipment IEC60601
- Experience in the medical device industry as well as in-depth knowledge of the worldwide Medical Device Regulation
- Technical knowledge and understanding of a range of disciplines relevant to a high reliability, robust and safety critical, complex electro-mechanical robotic system
- Experience in the creation of technical files, design dossiers and design history for regulatory submissions
- An advanced degree in Science or Engineering combined with experience of new technology development and research management
- Experience in Directing and controlling new product development and market introduction in highly regulated but fast paced, technically challenging environments.
- A strong attention to detail and the ability to multi-task and balance competing priorities
- The ability to get up to speed quickly and effectively build relationships between Regulatory Affairs and other areas of the organisation
- Effective communications skills, with experience of presenting plans in a clear and pragmatic way to colleagues and stakeholders across all levels
- A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues and suggest and implement improvements/ efficiencies to existing processes
If you would like to be considered for this role, please apply to send a copy of your full CV – or call us now.
Whilst this position may not be of interest to you or suit your skills and experience, please don’t hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.
We receive a large number of applications for all of our positions – Therefore, If you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion.
Candidates must be eligible to work and live in the UK