Manager, Regulatory - Mississauga, Canada - IMS

IMS

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 crossfunctional 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 qualityrelated 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
Indepth knowledge of relevant regulatory requirements and standards, such as FDA QSR, ISO 13485, and IEC 6230
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 crossfunctional teams, regulatory authorities, and auditors.
Selfmotivated and able to work effectively with mínimal supervision.
Demonstrative problemsolving abilities and a proactive, resultsoriented 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: