QA/RA Specialist - Boston, United States - Walker Cole International

Description

Walker Cole International is searching for a QA/RA 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 Industry
• Strong working knowledge of Quality Management Systems including ISO13485 requirements.
• Experience working with FDA Submissions, In Vitro Diagnostics products, IVDD/IVDR.

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