- Regulatory and Compliance
- United Kingdom - Malmesbury Office
About the role
As a lead Regulatory Specialist, with a specialism in Home Healthcare electronic devices, you will be instrumental to our continued innovation in exciting new product portfolios and technologies.
The Regulatory Affairs team is a group of experienced regulatory specialists offering expertise across the full product life cycle, i.e. regulatory strategy/pathways, dossier compilation/submission and post-submission/post-market maintenance. This role will work closely with development engineers from product conception and be involved in outlining the development process for new and innovative products.
The role of the Lead regulatory specialist is to guide the technical regulatory work of regulatory specialists working on Home Healthcare electronics within the regulatory Affairs team. They will be required to identify, organise, and contribute to work required to meet the regulatory requirements associated with development of electronic medical devices and create a strategy for the successful approval of medical devices globally.
Provide expert advice to stakeholders to support the design, development, and successful approval of Home Healthcare electronic , globally
Develop and manage appropriate technical device files in conjunction with the Regulatory affairs manager and relevant principal Regulatory Specialist
Design and place appropriate work packages (studies, process, files etc) to meet applicable regulatory guidance i.e. EU MDR/MDD, FDA
Create and maintain Technical Files, Design Dossiers, PMA and 510(k) files
Act as point of contact and Liaise with notified bodies, Competent Authorities, external accredited test facilities and relevant regulators
Lead global regulatory submissions supporting medical devices
Develop and implement global regulatory strategies for development, submission, registration, and maintenance of relevant Home Healthcare electronic / electronic medical devices
Ensure regulatory and standards updates effectively monitored and communicated
Provide guidance, training and mentorship to junior colleagues
Using your experience of obtaining a wide range of global product approvals and registrations of home healthcare and consumer goods products you will be responsible for the technical leadership of a small and specialist team assessing new products for medical device implications and setting out the requirements for product design and development, ensuring that all requirements are known as we develop our new and future product portfolios.
Engineering degree or equivalent (Electrical/Electronic or Biomedical preferred?)
Knowledge and experience of applicable regulations relating to the design development and supply of electronic medical devices within the UK, EU, US and China, (knowledge of other markets is also desirable)
Experience of compiling Technical Documentation to successfully meet MDR and FDA Requirements.
Knowledge of the requirements for Medical Electrical Equipment Systems (IEC 60601 family); risk management of medical devices (IEC 14971); also desirable, Medical Device Software (IEC 62304) and Usability Engineering (IEC 62366).
Active role in internal and external audits and assessments including: liaising with Notified Bodies, Competent Authorities and external accredited product test facilities.
Performance related bonus
Company paid Life Assurance
Discounts on Dyson machines
Competitive pension scheme
Purchase additional holidays
27 days holiday plus statutory bank holidays
Free bus travel to and from Malmesbury campus from Bristol, Chippenham and Swindon
Endless free coffee and tea, and a free lunch
Free on-site hair salon
On-site lifestyle Assist
Electric vehicle scheme
Private Medical insurance for all employees
Employee Assistance Program for employee and dependents
Digital GP and prescription service
Fertility treatment support
On-site gym and sports centre
On-site wellbeing centre
Dyson is an equal opportunity employer. We know that great minds don’t think alike, and it takes all kinds of minds to make our technology so unique. We welcome applications from all backgrounds and employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other any other dimension of diversity.
We are following the government guidelines regarding COVID19. At this time all interviews will be conducted via video or telephone. We’re taking these precautionary measures to protect both our employee and candidate wellbeing. Our Talent Acquisition team will work with you and provide further information as appropriate.