Lead Regulatory Specialist - medical
A wonderful opportunity to join a premium brand in the world of electrical and electronic appliances. Their innovative products and numerous patented designs have won them plaudits all over the world. They are driven and thrive on challenges of relentless improvement.
As a
Lead Regulatory Specialist
, with a specialism in medical 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.
Within this senior role, you will guide and advise the technical regulatory work of medical device specialists within the regulatory Affairs team. You 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.
Responsibilities
Provide expert advice to stakeholders to support the design, development, and successful approval of medical device(s), 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 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 the NPI portfolio develops.
The Person
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.
The Rewards
A very attractive salary package awaits the right individual along with a whole host of benefits including:
Career development and growth in a global team
27 days holiday plus eight statutory bank holidays
Performance related bonus
Pension scheme
Life assurance
Discounts on company products
Subsidised café and restaurants
Free on-site parking
Sport centre
Interested?
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If you have any questions please feel free to email direct to (url removed) or call (phone number removed)
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