Medical Records Quality Assurance jobs

Regulatory Affairs & Quality Assurance Manager - Medical Devices

Company: Vivosonic Inc.
Location: Toronto, ON
Job Type: Permanent, Full-time
Work Arrangement: Office-based role, currently on a temporary hybrid schedule
Salary Range: $75,000–$92,000 annually, based on experience and qualifications

About Vivosonic

Vivosonic is a medical device company specializing in auditory diagnostic technology. We design, manufacture, and support innovative systems used by hearing healthcare professionals in Canada and internationally.

We operate under an ISO 13485-registered and MDSAP-compliant Quality Management System (QMS) and support regulatory requirements across multiple global markets. Our QMS is a tool that enables the company to develop quality products, meet its quality objectives, and comply with applicable regulatory requirements.

About the Role

We are looking for a Regulatory Affairs & Quality Assurance Manager to own Vivosonic’s regulatory and quality functions and the QMS itself.

This is a hands-on role in a small medical device company. The successful candidate will act as the primary RA/QA resource for the company and will serve as the Company’s Quality Management Representative. The successful candidate must be able to provide documentation supporting their education, training, skills, and experience, as required for ISO 13485 audit records.

The role requires someone who can exercise independent judgment while working closely with R&D, Operations, and senior leadership. The successful candidate must be comfortable taking ownership of both high-level compliance responsibilities and detailed day-to-day execution.

Key Responsibilities

• Maintain and improve the Quality Management System in accordance with ISO 13485, MDSAP, Health Canada, FDA, EU MDR, ISO 14971, and other applicable medical device requirements.
• Serve as the Company’s Quality Management Representative and ensure the QMS is maintained, implemented, monitored, and reported to senior management as required.
• Lead preparation for internal and external audits, participate in audits, respond to audit findings, and support ongoing audit readiness.
• Schedule and run Management Review Meetings, prepare quality reporting, track action items, and support continuous improvement activities.
• Manage and execute core QMS processes, including document control, technical documentation, CAPA, complaints, change control, post-market activities, vigilance reporting, final inspection, product release, and training records.
• Lead and coordinate regulatory submissions, product registrations, licence renewals, and regulatory maintenance activities.
• Coordinate with external regulatory agents, local representatives, distributors, and authorities as needed to support product compliance in active markets.
• Monitor regulatory and standards updates and assess their impact on products, labelling, technical documentation, and QMS processes.
• Lead risk management activities and support product development through design reviews, ECOs, CAPAs, verification/validation documentation, technical files, and Instructions for Use.
• Provide practical quality and regulatory guidance to cross-functional teams.
• Maintain records that demonstrate employee competence, training, and audit readiness for applicable quality and regulatory activities.

Required Qualifications

• Bachelor’s degree in science, engineering, biomedical engineering, regulatory affairs, quality, medical technology, or a related discipline.
• 5+ years of Regulatory Affairs and/or Quality Assurance experience in the medical device industry.
• Experience working within an ISO 13485-regulated medical device Quality Management System.
• Documented ISO 13485 and/or QMS-related training, or equivalent documented experience, suitable for inclusion in the employee’s ISO audit file.
• Experience supporting or acting in a Quality Management Representative role, or equivalent responsibility within a medical device QMS.
• Working knowledge of MDSAP, Health Canada requirements, FDA 21 CFR Part 820 / QMSR, EU MDR, ISO 14971, and design controls.
• Experience with audits, CAPA, complaints, change control, post-market surveillance, technical documentation, and regulatory submissions.
• Strong technical writing, organization, communication, and problem-solving skills.
• Ability to work independently and manage multiple priorities in a small-company environment.

Preferred Qualifications

• Experience with electro-medical devices, diagnostic equipment, software-enabled medical devices, or audiology/neurology-related products.
• Experience with IEC 60601-1, IEC 60601-1-2, IEC 62304, technical files, labelling, and IFU documentation.
• Experience with NetSuite, ERP systems, eQMS platforms, or electronic document control systems.
• Professional training or certifications related to QMS operations, such as ISO 13485 training, ISO 13485 Internal Auditor, ISO 13485 Lead Auditor, ISO 14971 Risk Management, RAC, CQA, MDSAP training, CAPA training, complaint handling, or document control training, are considered assets.
• Relevant documented work experience may be considered in place of formal certificates.
• P.Eng. designation is an asset but not required.

What We’re Looking For

We are looking for someone who is highly organized, detail-oriented, practical, collaborative, and comfortable taking ownership across both technical and administrative responsibilities, including direct execution of final inspection.

The right candidate exercises independent judgment, keeps compliance practical and proportionate rather than bureaucratic, and takes full ownership of a strong, mature system — maintaining what works while continuing to improve it.

This role is best suited for someone who is hands-on, accountable, and comfortable being the primary quality and regulatory resource in a small medical device company.

Pay: $75,000.00-$92,000.00 per year

Benefits:

• Dental care
• Extended health care
• Flexible schedule
• Tuition reimbursement
• Vision care

Application question(s):

• Do you have experience acting as a Management Representative or supporting ISO 13485 audits, including required quality training and audit preparation?
• Do you have hands-on experience with medical device audits?
• Are you legally entitled to work in Canada?

Work Location: Hybrid remote in Etobicoke, ON M9C 5K5