Regulatory Lead

Company Description Come join us and make a difference in the world We’re NEC Software Solutions (part of global tech giant NEC Corporation). While you read this ad, our software is helping to dispatch ambulances, support families, keep trains on the move, locate missing people and even test the hearing of newborn babies. Working with us, you’ll be helping our 3,000+ employees push the boundaries of what’s possible and support amazing public services. We work with governments, hospitals, police forces, housing providers, local authorities and more. We help them pay financial support faster, speed up treatments for patients and respond to emergencies in the right way. The more we do, the more our customers can do for others. And together, we make a world of difference. We’d love your help. And we’ll support you all the way. **Job Description**: Here at NEC Software Solutions we are involved in numerous Healthcare Programmes projects across the UK and Ireland. Our teams work with Newborn Hearing Screening, Diabetic Eye Screening, and various other healthcare projects. The great work we’re doing is having a massive impact across communities, including reducing wait times, offering personal support for individuals, and allowing for an efficient and smooth service. As part of this work, we use our own Software - which is considered a Class IIa Medical Device. We’re keen to ensure that not only are our patients getting the best possible experience - but also to ensure our Devices are all up to date, approved and certified. This has allowed us to begin our search for a Regulatory Lead. the Regulatory Lead will be responsible for managing the compliance against the company's portfolio. This will be a varied position working across several different product ranges with varying customers and standards. Initially there will be an element of QMS Management and ensuring ISO:13485 standards are adhered to. However, the role will evolve over time and be completely focused on regulatory compliance. Whilst there is space for collaborative work, and a compliance team already established in the business - the remit of this role will very much fall under the control of the incumbent for this position - so experience with achieving these classifications is essential to us. This is a pivotal role for us - as classification will allow NECSWS to continue to provide the support and services we are offering to individuals across the whole of the UK and Ireland. **Main Responsibilities**: - Work with our Compliance and Governance Teams, to obtain CE and CA Classification, complete Technical Files and Declarations, and be responsible for all submissions to the MHRA. - Be the operational medical device regulatory affairs "go-to" person for the company, providing advice to other departments - Manage day-to-day Regulatory Affairs activities providing guidance and advising, and making key regulatory decisions - Planning, coordination, and management of regulatory documentation activities - i.e., post-market surveillance reports, risk management plans/reports, regulatory submissions etc. - Review of all Medical Device Files to ensure adequate compliance and notification of any significant changes to ensure authorisation is retained. - Maintenance and updating of Regulatory procedures and processes to ensure continued compliance. - Time Management and Deadline meeting of all regulatory processes. - The supporting and running of any internal and external audits - Lead, mentor and train other individuals in the business - to ensure regulations are met across the board. - Design, Develop and implement a regulatory strategy - be responsible for assessing all of the health products in terms of Software as a Medical Device (SaMD) and ensuring that we are ahead of any ongoing regulatory and legislative changes to Medical Devices. - Coordinate inspection of the organisation and contract facilities and develop procedures to ensure regulatory compliance **Qualifications**: **Essential**: - Significant experience working in a Regulatory Compliance Role - Extensive and demonstrable knowledge of regulatory requirements - specifically MDD & MDR - Strong understanding of assessing health products in terms of Software as a Medical Device - Demonstrable Experience of submitting various documents to regulatory committees and governing bodies - An in depth understanding of current Medical Device Regulations, with a passion for keeping up to date with market changes. - QA/RA experience in a regulated environment (e.g., ISO 13485:2016) - Ability to drive standards **Desirable**: - Knowledge of Diabetic Eye or Newborn Hearing Screening - Experience leading a regulatory function or being the most senior member within the team Additional Information We pride ourselves in offering an excellent benefits package, including an above average pension scheme. When you join the team at NEC Software Solutions, you are provided with the follow