Quality System and Regulatory Affairs Specialist

Job Application and Information for:
Job - Quality System and Regulatory Affairs Specialist (Ottawa Based)
Position Overview

We are currently seeking a detail-oriented Quality System Associate/Specialist to join our team, who is also well-versed in EU MDR and FDA medical device regulations. This position includes the following responsibilities:

• Supporting the implementation, maintenance, and ongoing improvement of our Quality Management System (QMS), to ensure compliance with FDA QSR/QMSR and ISO 13485:2016, focusing on Software as a Medical Device (SaMD) products.
• To lead and coordinate the certification process for Software as a Medical Device (SaMD) in compliance with EU Medical Device Regulation (MDR), including the preparation of all required documentation. Responsibilities also extend to preparing submissions to the US FDA, building on our existing Class II SaMD designation.
• The candidate will work closely external Quality System and Regulatory consultants who will provide strategic guidance on an ongoing basis; we view Quality Systems and Regulatory Affairs as critical functions to our business and are seeking to build in-house expertise with this position.

• Assist in developing, maintaining and improving the Quality Management System in accordance with FDA 21 CFR Part 820 (QSR/QMSR) and ISO 13485:2016 requirements.
• Support the development, review, and revision of quality system procedures, work instructions, and forms.
• Maintain document control processes ensuring proper version control, distribution, and archival of quality documentation.
• Coordinate and track management review meetings and follow-up action items.

• Prepare for regulatory compliance with the EU Medical Device Regulation, to gain approval for our SaMD platform to be used in neurology clinics throughout the EU.
• Prepare regulatory submissions to the US FDA, in support of new platform features & functionality that we plan to introduce to the US market, while building on our existing Class II Software as a Medical Device designation.
• Prepare and compile technical documentation, including design dossiers, risk management files, clinical evaluation reports and testing data.
• Ensure compliance with EU MDR (Regulation (EU) 2017/745), and related standards, as well as FDA 21 CFR Part 820, 21 CFR Part 11.
• Coordinate with cross-functional teams including management team, operations and engineering to gather required documentation.
• Serve as the primary liaison with regulatory authorities, respond to queries, and facilitate audits and inspections.
• Support post-market surveillance and reporting requirements to maintain compliance.
• Conduct gap analyses and implement corrective actions to address compliance issues.

• Coordinate quality training program and maintain training records.
• Support supplier quality activities and vendor audits.
• Maintain quality records in compliance with regulatory requirements.
• Manage and track corrective and preventive action (CAPA) processes.
• Investigate quality issues and non-conformances, documenting findings and driving resolution.
• Analyze quality metrics and trends to identify opportunities for system improvements.
• Support risk management activities including risk assessments and FMEA exercises.

• Track and communicate regulatory changes that impact quality system requirements.
• Support quality activities related to software medical device development and lifecycle management.
• Participate in software design reviews and verification/validation activities as the quality system representative.
• Support software life cycle processes adherence with IEC 62304 and other applicable standards.
• Support internal and external audits including FDA inspections, ISO certification audits, and Notified Body assessments.

• College diploma or bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs or related field.
• Experience in regulatory affairs for medical devices, specifically SaMD
• In-depth knowledge of EU MDR, ISO 13485, IEC 62304, FDA QSR (21 CFR Part 820), ISO 13485:2016 and other relevant standards.
• Proven experience in successful regulatory submissions and obtaining approvals for SaMD products.
• Excellent communication, project management, and problem-solving skills.
• Ability to interpret complex regulatory language and implications for product development.

• Working knowledge of FDA Quality System Regulation (21 CFR Part 820).
• Understanding of ISO 13485:2016 requirements and implementation.
• Working knowledge of Software as a Medical Device regulatory framework (IEC 62304, FDA guidance).
• Knowledge of risk management standards (ISO 14971).
• Understanding of design controls and product lifecycle management for SaMD.
• Familiarity with cybersecurity requirements for medical devices.
• Certification in Quality Management Systems
• Certification in Regulatory Affairs (RAC) or equivalent…