Regulatory Affairs (RA) Officer – Edinburgh – Medical Devices
SRG are delighted to be working with an internationally renowned medical device manufacturer. As part of continued growth this organisation are looking for a Regulatory Affairs (RA) Officer to join their team in the greater Edinburgh area.
The Role
As RA Officer you will work as part of a large, multinational team to help manage and deliver product license registration, working in collaboration with regulatory bodies across the globe.
As part of the RA team you will help build the company's regulatory strategy, determine requirements and propose solutions to ensure compliance. On a day-to-day basis this involves the preparation of regulatory documentation and subsequent submission across the US, UK and EU as well as other appropriate territories in line with local guidance.
This position also requires constant communication internally to ensure that staff members are aware of data and information requirements to allow for successful license applications. The RA team are also involved in the development of product labelling for in-house products as well as for some 3rd party products as and when required.
The Right Person
* Prior experience in a regulatory role – ideally within an FDA licensed manufacturing facility.
* Previous experience within the medical device sector is essential, anyone with prior experience working with IVDs would be preferential.
* Excellent communication skills are essential
* Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
What’s in it for you?
This position offers a competitive base salary with a wide array of benefits available. As well as this you will be offered a variety of opportunities for personal development working within a large multi-national team. Want to know more? Hit apply.