Description
My Client is looking for a Regulatory Affairs Manager, with a minimum of 3 years experience within the medical device industry. The ideal candidate will have knowledge of medical device legislation in the US, CAN, AUS and their guidelines. You will have knowledge of quality management system requirements to ISO 13485, with a relevant Life Sciences Degree. Fluency in French would be a bonus. Main duties will include monitoring the legislative environment of US, CAN & US. You will maintain an overview of regulatory requirements and changes in the area. You will monitor submission deadlines and timely responses to requests by required Authorities and bodies. You will be in charge of the development of Technical files as well as summary technical documentation. You will support international product registration by consulting the Director for International projects.