Regulatory Affairs Manager
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| Job Type | Permanent |
| Location | High Wycombe |
| Area | Buckinghamshire, England |
| Sector | Manufacturing - Scientific |
| Salary | £45000 - £55000 per annum, Benefits: WFH flexibility |
| Currency | GBP |
| Start Date | ASAP |
| Advertiser | Tom Davies |
| Job Ref | ER13338TD |
- Description
- Regulatory Affairs Manager
Flexible with working from home.
Working for a class 2 medical device company with some big ideas for future technology, this position is crucial for the successful expansion and growth of this company. They are making a big impact in the medical device industry and although at early stages they are very well established and have ambitious plans.
You will join a small, tight-knit team and be the regulatory specialist, responsible for the day to day management of the regulatory function. You will have no direct repots as the Regulatory Affairs Manager, but this will be part of the internal expansion and growth plans for the future. Personal development is a big part of this company culture and a development plan will be put in place from the outset with extensive training to help you reach your goals and step up with in the business.
Their products and technology are the driving force and they have strong belief in them, the technology has been described as a real game changer and they are at an exciting part of their journey. With the development and release of brand new products to the market you will be responsible for getting registration for these products and directly submitting and maintain regulatory approvals. They operate in global markets including (but not limited to) EU, USA, Brazil, Canada, and Australia so an understanding of different regulations and experience working in these markets will be beneficial.
The products are having a huge impact on patients’ lives with huge potential for the technology to be used in a diverse range of applications. As well as medical another application they have been successful in is the sports industry, helping with athlete’s recovery and other applications are been explored.
They are looking for someone with strong regulatory experience within the medical devices industry, you will have a minimum of 5 years’ experience with a strong academic background in a scientific discipline. They work with Class 2 devices so ideally you would have worked with similar or even Class 3 devices, another big benefit would be having experience with electrical medical devices.
Responsibilities would include:
- Preparation and submission of regulatory approvals
- Maintaining and renewing approvals, licences, clearance and certifications
- Maintaining Medical Device Files and other technical documentation
- Ensuring compliance with all applicable standards and regulations for medical devices
- Rapid expansion into new markets and territories along with the launch of new product upgrades are planned, requiring new and amended regulatory clearances.
- Strong background in regulatory affairs for medical devices, with at least 5 years of relevant experience.
- Detailed knowledge and experience of EU regulations (MDR) and guidance is essential
- Good knowledge of ISO13485 and ISO14971 required
- Educated to degree level in a relevant discipline. Preferably a science, engineering or technology background.
