Regulatory affairs franchise lead-mdr compliance - (North Andover, MA)

Location: Andover, MA Job summary Responsibilities: (Please specify % amount against each responsibility) (20%) Line Management of MDR RA Franchise team (20%) Provides expert advice on understanding and implementing the MDR Regulation for the franchise and the wider S&N Business. Initial point of contact for all RA related issues at franchise level and works closely with other franchise leads. (20%) Responsible for delivering the MDR RA program for the franchise. Generates, tracks and reports metrics up to RA Senior Director. Deputises for Regulatory Affairs Senior Director where required. (10%) Hosts, manages and prepares for all Notified Body audits. Maintains positive relationship with the notified body. (20%) Responsible for delivering changes to the global markets. Approval of Technical Files and Design Dossiers (10%) Trains in Regulatory qualifications into franchise and acts as mentor during this process. Audits other areas of the business to MDR qualifications.