Senior 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 Senior Regulatory Affairs (RA) Officer to join their team in the greater Edinburgh area.
The Role
As Senior 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 a key 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.
You will be required to work closely with internal and external stakeholders to ensure all staff and vendors are kept aware of developments and changes in global regulatory requirements. As Senior RA officer you will also be responsible for managing and confirming compliance issues both internally and externally, ensuring all relevant documentation is kept accurate and up-to-date.
The Right Person
* Prior experience in a regulatory role within an FDA licensed manufacturing facility.
* Significant previous experience within the medical device sector is essential, anyone with prior experience working with IVDs would be preferential.
* Excellent communication skills are essential
* Expert-level knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
* Demonstrable experience supporting regulatory audits and inspections
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.