Manager, Regulatory

Working with us you’ll have a unique opportunity to experience the evolving technological frontier

**Job Purpose**

**Duties and Responsibilities**

Specifically, but not limited to:

- Develop, implement and maintain a comprehensive quality management system and processes in accordance with applicable regulatory requirements (e.g., FDA QSR, ISO 13485, IEC 62304, ISO 14971, Health Canada)
- Lead product risk assessments and develop risk management strategies in collaboration with the risk management team to mitigate potential hazards associated with SaMD products.
- Facilitate annual internal audits to ensure compliance with regulatory requirements and industry standards.
- Collaborate closely with cross-functional teams, including engineering and software testing, to establish quality objectives and other quality priorities.
- Serve as the primary point of contact for regulatory agencies, notified bodies, auditing organizations, and other external stakeholders on quality-related matters.
- Host external audits and inspections (customer, ISO, regulatory).
- Manage corrective action/preventive action (CAPA), document control, quality management system training, and supplier qualification and monitoring processes.
- Manage and coach direct reports, providing the team with a strategic vision, guidance, training, and support, as needed.
- Monitor and analyze quality performance metrics to identify trends, areas for improvement, and process optimization opportunities.
- Stay informed about emerging trends, developments, and best practices in quality assurance and regulatory compliance within the medical device industry and adapt quality system processes to accommodate.
- Maintain and evolve quality system documentation owned by the quality department.
- Recommend and drive continuous improvement initiatives to enhance the efficiency, effectiveness and reliability of our quality management processes.
- Manage the overall operational, budgetary, and financial responsibilities and activities of the Team.
- Maintain company ISO certifications and regulatory registrations.

**Qualifications**
- Bachelor’s degree in engineering, computer science, or a related field; advanced degree preferred
- 5+ years of experience in quality assurance within the healthcare technology industry
- In-depth knowledge of relevant regulatory requirements and standards, such as FDA QSR, ISO 13485, and IEC 62304.
- Strong understanding of software development lifecycle (SDLC) methodologies and software validation principles.
- Proven experience in developing, implementing and maintaining quality management systems and processes.
- Excellent leadership, negotiation and communication skills, with the ability to effectively collaborate with and influence cross-functional teams, regulatory authorities, and auditors.
- Self-motivated and able to work effectively with mínimal supervision.
- Demonstrative problem-solving abilities and a proactive, results-oriented mindset.
- Prior experience with SaMD products or digital health technologies is highly desirable.
- Proven ability to exercise discretion in the handling of patient and other forms of confidential information.
- Certification(s) in quality management and/or regulatory affairs (e.g. ASQ Certified Quality Manager, Six Sigma, Regulatory Affairs Certificate (RAC), lead auditor certification).

**Benefits**
- Competitive salary
- Comprehensive health, dental, benefit package
- Flexible work schedule and remote work options
- Opportunities for professional development and career growth.
- A collaborative and dynamic work environment with passionate, talented colleagues
- The chance to make a meaningful impact on healthcare through innovative technology solutions

**Job Types**: Full-time, Permanent

Pay: $75,000.00-$110,000.00 per year

**Benefits**:

- Company events
- Dental care
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Application question(s):

- Willing to go to the office once a week.

**Experience**:

- quality assurance: 3 years (required)

Work Location: Hybrid remote in Mississauga, ON L4W 5K4