QA/RA Manager - Medical Device

About the Company

Bioscan Research is a MedTech company developing advanced diagnostic and monitoring solutions for brain injuries and trauma care. Our flagship device, CEREBO, is a non-invasive, handheld system leveraging near-infrared spectroscopy and machine learning to detect intracranial injuries such as bleeds and edema. As we expand into regulated markets including the United States and Europe, we are seeking an experienced QA/RA Manager to lead quality and regulatory functions across the organization.

Role Summary

The QA/RA Manager will be responsible for implementing and maintaining the Quality Management System (QMS) in alignment with international medical device standards, as well as leading regulatory affairs activities required for product approvals and ongoing compliance. This role requires close collaboration with cross-functional teams including R&D, Clinical, Manufacturing, and Leadership.

Key Responsibilities

Quality Assurance (QA):

• Lead the implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, 21 CFR 820, and other applicable standards
• Oversee documentation control, change management, non-conformances, CAPA, internal audits, and employee training programs
• Ensure design control, risk management, process validation, and device history records are maintained accurately and consistently
• Coordinate management reviews, supplier qualification, and audit readiness activities
• Own and maintain key documents such as QSPs, SOPs, and the Device Master Record

Regulatory Affairs (RA):

• Prepare and manage regulatory submissions including US FDA 510(k), CE marking under MDR, CDSCO registration, and other international requirements
• Monitor and interpret global regulatory changes and integrate them into internal processes and product development lifecycles
• Maintain the Essential Principles Checklist, GSPR documentation, and support compliance with labeling, UDI, and PMS requirements
• Coordinate with external consultants, testing laboratories, and notified bodies as needed
• Support post-market surveillance activities and field safety corrective action procedures

Candidate Profile

• Bachelor’s or Master’s degree in Biomedical Engineering, Life Sciences, Quality Management, or related field
• Minimum of 2-5 years of relevant experience in a QA/RA role within a medical device company
• Strong knowledge of ISO 13485, IEC 62304, ISO 14971, 21 CFR 820, EU MDR, and applicable national regulatory frameworks
• Demonstrated experience in leading or supporting regulatory submissions and quality audits
• Strong documentation, communication, and analytical skills
• Ability to work independently and cross-functionally in a dynamic, high-growth environment
• Experience with hardware, embedded firmware, or connected health systems is preferred