Associate Quality and Regulatory Affairs Engineer

About the Company

ImmersiveTouch is a medical device company transforming surgical planning through virtual reality (VR), augmented reality (AR), and precision 3D printing technologies. Our platform enables surgeons to visualize, plan, and rehearse complex procedures using patient specific anatomy and immersive technologies. We develop Software as a Medical Device (SaMD), anatomical models, and surgical planning solutions used across leading healthcare institutions.

About the Role

ImmersiveTouch is seeking a motivated and detail-oriented Associate Quality and Regulatory Affairs Engineer to join our Quality and Regulatory Affairs team. This individual will support Quality Management System (QMS) activities, product documentation, software quality processes, and regulatory compliance initiatives across the organization.

This role is ideal for someone interested in medical devices, software quality, regulatory affairs, and innovative healthcare technologies within a fast-paced environment.

Responsibilities

• Support preparation and maintenance of controlled quality system documents including SOPs, Work Instructions, protocols, reports, forms, and training records
• Assist with document control activities within Greenlight Guru, including revisions, approvals, training assignments, and traceability
• Support quality system activities including CAPAs, nonconformances (NCs), complaints, deviations, and change controls
• Participate in software verification and validation activities, including execution of test protocols and documentation of results
• Assist with internal and external audit preparation activities and audit remediation efforts
• Support design control and product release activities, including traceability documentation and quality record review
• Assist with regulatory documentation activities including Letters to File and FDA submission support
• Collaborate with Product Development, Operations, Manufacturing, and Surgical Planning teams to support compliant product development activities
• Support continuous improvement initiatives related to Quality and Regulatory processes

Qualifications

• Bachelor’s degree in biomedical engineering, Quality Assurance, Life Sciences, or a related field
• 0 to 2 years of experience in Quality Assurance, Regulatory Affairs, or medical device related roles preferred
• Familiarity with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), and medical device quality systems preferred
• Basic understanding of Software as a Medical Device (SaMD) concepts and IEC 62304 preferred
• Strong organizational, technical writing, and documentation skills
• Ability to manage multiple priorities in a fast-paced startup environment
• Experience with Microsoft Office Suite including Word, Excel, and PowerPoint
• Experience with electronic Quality Management Systems is a plus
• Interest in VR/AR technologies, 3D printing, surgical planning, or medical device innovation preferred

Why Join Us

• Work on cutting edge VR/AR and surgical planning technologies
• Gain hands on experience in both software and hardware medical device quality systems
• Collaborate with a highly driven and innovative team
• Contribute to products that directly impact patient care and surgical outcomes

Apply to join a team redefining the future of surgery through immersive technology.