Regulatory Affairs Specialist

General Responsibilities include;

* Directing and advising team on their regulatory procedures on the new medical device project.
* Writing and developing Medical Device Technical files.
* Maintaining Contact and submitting relevant documentation to the MHRA and FDA.
* Leading project from its current position through regulatory submissions, right through to product registration.

Key skills needed;

* 5+ year's regulatory experience of Regulatory Affairs within a medical device environment.
* Ability to display and advise on regulatory requirements to ISO 13485 standards.
* Familiar with submission within theUKandUSAis essential; EU would be beneficial but not essential.
* Experience of leading projects would also be a bonus but not essential.
* Experience of active medical devices is a strong requirement.

Other Information

* Working from home is something that this role will also allow as long as 2 days on site can be achieved.

My client is looking to move fast so if you believe you are suitable or know of someone who is please contact Joseph.To find out more about Real please visit www.realstaffing.com