KA Imaging is a spin-off company from the University of Waterloo. We are rapidly growing, with dedicated facilities based out of Kitchener-Waterloo, Ontario. KA Imaging is committed to expanding our team of professionals to include talented and dedicated individuals to be part of a highly focused and dynamic team. 


The company prides itself on its hardworking and self-motivated employees with an interest in creating a positive impact in society. If this sounds like you, please submit your cover letter and resume for the posted position. 


Innovative X-ray everywhere


To enable our employees the freedom to innovate and create high performance products for our customers, using cutting edge advances in X-ray technologies.


Embrace challenge – be innovative Respect – everyone, including yourself Over-communicate – share information regularly to create alignment and focus Integrity – Doing the right thing, even when no one is looking Positive Attitude – Anything is possible Put People First – KA’s success is because of its employees, customers, and shareholders


Job Description Overview:

KA Imaging has innovated a novel color X-ray detector that can visualize bone and soft tissue separately. We have several issued patents that protect the technology and our product pipeline includes a CAT scan replacement product which enables better visualization than traditional X-rays. We are 510k and Health Canada cleared. We are looking for an individual that is energetic, self-driven and can drive the teams to provide necessary information required for regulatory submissions.

The RA/QA Manager will be responsible for assuring the implementation of regulatory affairs and quality assurance systems and procedures relating to ISO 13485, MDSAP, FDA, Health Canada, European Union MDR and other regulations as required. The RA/QA Manager will be the Management Representative and is responsible for ensuring compliance with medical device regulations in Canada, US, EU and other jurisdictions where KA Imaging medical devices are distributed.


Duties Include, but not limited to:

  • Creating the quality manual and ensuring the quality manual and related procedures are up to date and compliant
  • Creating and ensuring all procedures and practices meet regulatory requirements Creation and/or revision of quality system procedures and work instructions Managing engineering change orders using PLM system
  • Scheduling, preparing presentations to provide project updates or issues needing resolution
  • Coordinating with other groups (Engineering, Supply Chain, Quality, Manufacturing, etc.) to ensure accurate, complete, and efficient updates to the procedures
  • Create project plans and act as project manager to implement plans in QA and RA
  • Prepare regulatory submissions and related maintenance documentation (amendments, supplements, annual reports, Device History File, Device Master Record, etc.) for Regulatory Health Authorities within defined time schedule.
  • Manage site compliance documents such as GMP certifications and site registration documents.
  • Determines regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities
  • Acts as regulatory liaisons and single point of contact in meetings and interact with members other project team and sub-teams;
  • Review all changes (change control) to manufacturing processes and laboratory methods and specifications to ensure compliance with regulatory guidelines and to maintain adequate control and flexibility for the life cycle management of the product.



  • B.S./M.S. in Engineering or Sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry, etc.)
  • In-depth understanding of good documentation practices
  • Strong working knowledge of writing, editing, proofreading, English spelling, grammar, and punctuation
  • Must be able to work independently with minimal supervision Strong independent judgment and decision-making abilities required. Strong knowledge of relevant regulatory guidance.


Our organization commits to an equitable, inclusive and barrier-free recruitment and selection process. We encourage applications from Indigenous, Black, racialized and 2SLGBTQ+ persons and other equity-deserving groups.

We welcome applications from individuals with disabilities. Our organization will accommodate the needs of applicants throughout the hiring and selection process under the Human Rights Code and Accessibility for Ontarians with Disabilities Act (AODA). Accommodations are available upon request for candidates taking part in all aspects of the selection process.

Job Types: Full-time


  • Casual dress
  • Dental care
  • Extended health care
  • Life insurance
  • On-site parking
  • Paid time off
  • Vision care

Flexible Language Requirement:

  • French not required


  • Monday to Friday


  • Bachelor’s Degree (preferred)


  • medical device regulations in Canada, US, EU: 3 years (preferred)
  • implementation of RA and QA systems and procedures: 3 years (preferred)

Work Location: Hybrid remote in Waterloo, ON

Click here to apply

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