Job Description:

Walker Cole International is searching for a QARA Specialist to join a Global Medical Device business in Massachusetts, Boston. As part of this role you will manage a the regulatory compliance of a range of medical devices including IVD's (In Vitro Diagnostics) focussing on ensuring compliance through QMS management and complaint management.Your responsibilities will be to:Manage regulatory compliance using a regulatory tracker in line with FDA Guidelines and manage both new and existing 510(k) entries. Oversee the Quality Management System (QMS) to ensure compliance with international standards including ISO13485. Lead the complaint management and post-market surveillance activities and maintain compliance to the systems for change controls and Corrective & Preventive Actions (CAPA's) to ensure product safety. Work collaboratively with product development teams, suppliers and contract manufacturers to ensure regulatory compliance is maintained, including changes to certification IVDD to IVDR.The successful Quality Manager will have:3+ years of experience in Regulatory Affairs within the Medical Devices IndustryStrong working knowledge of Quality Management Systems including ISO13485 requirements. Experience working with FDA Submissions, In Vitro Diagnostics products, IVDDIVDR.Regulatory Affairs | FDA | Medical Devices | CAPA | Corrective and Preventative Action | Quality | QMS | Quality Management System | | Audit | ISO13485 | IVDD | IVDR | 510(k) | Complaints | Post-Market Surveillance | Regulatory | Complaint | IVD | Class 2 | Class 3 | Self-Test