Based in St. Jacobs, Ontario, Huron Digital Pathology is on a mission to transform glass slides into shareable knowledge. Our Scan, Index, and Search solution for pathology combines award-winning TissueScope whole slide scanners with our AI-enabled Lagotto image search engine to connect pathologists, researchers and educators with the vast expertise of their colleagues to improve diagnosis and accelerate disease research.

We're applying unique Machine Learning (ML) and Artificial Intelligence (AI) technologies to develop solutions in Digital Pathology that are modernizing healthcare, including detecting cancer and other diseases.

Reporting directly to the President, theQuality and Regulatory Affairs Manageris responsible for overseeing the implementation, maintenance, and monitoring of the Quality Management System (QMS) for continued suitability and effectiveness.

It is the Quality and Regulatory Affairs Managers responsibility to ensure Huron Digital Pathology is adhering toISO13485 Medical devices Quality management systems Requirements for regulatory purposes and applicable regulatory requirements.

This role will have the responsibility and authority that includes:

• ensuring that processes needed for the quality management system are documented
• reporting to top management on the effectiveness of the quality management system and any need for improvement
• ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization

• conformity of the devices is appropriately checked, in accordance to the QMS under which the devices are manufactured, before a device is released
• technical documentation of the EU declaration of conformity are drawn up and kept up to date
• post-market surveillance obligations are complied with in accordance with manufacturer obligations and the reporting obligations are fulfilled

Other key responsibilities include:

• • Ensure processes are established, implemented, maintained and improved in accordance with ISO 13485 and applicable regulatory standards
  • Schedule and document actions from Quarterly Management and Scorecard reviews and provide assessment of the health of the QMS as part of the management review process.
  • Report to executive management on the performance of the quality management system
    
  • Identify any areas that require improvement through analysis of corrective/preventive action results
  • Act as liaison between Huron Digital Pathology and external QMS auditors
  • Prepare and conduct internal audit or QMS as needed

• • Develop, execute, and maintain the Internal Quality Audit Plan, to evaluate the complete QMS annually
  • Monitor ISO 13485 and applicable regulatory requirements for any changes or upcoming changes in standards or requirements, twice monthly, and provide recommendations to HDP Management, as applicable
  • Ensure the promotion of awareness of customer and regulatory requirements throughout Huron Digital Pathology
  • Assist in company personnel training related to the documented QMS policies and procedures
  • Oversee the risk assessment activities and ensure that product and process changes have been reflected in risk assessment updates, if applicable.

Preferred Qualifications:

• Minimum B.Sc. in biology, chemistry, or related discipline
• At least 5 years of experience in regulatory affairs
• Experience in capital equipment and medical devices
• Working knowledge of ISO 13485 and applicable regulatory standards
• Ability to analyze and interpret standards, technical procedures and governmental guidance and regulation documents
• Excellent verbal and written communication skills
• Effective problem-solving skills, demonstrated project management skills and experience
• Proficiency in Microsoft Office (Word, Excel) and SharePoint
• RAQ Certification would be an asset

We offer a competitive compensation package and bonuses, vacation allowance and employee benefits plan. Visit us atwww.hurondigitalpathology.com.

We thank all applicants for their interest and wish to advise that only those candidates selected for an interview will be contacted. Appropriate accommodations will be provided upon request throughout the recruitment and employment process as required under theAccessibility for Ontarians with Disabilities Act(AODA).