Regulatory Affairs / QMS Analyst

About Circle Cardiovascular Imaging:

Circle’s vision is to enable healthier Lives through better imaging by transforming cardiac magnetic resonance imaging (MR) and other advanced imaging technologies to improve Cardiovascular Care. Circle Cardiovascular’ s CVI42 is the Cardiac MR market leader imaging processing software.

Circle Cardiovascular Imaging (Circle) designs, builds, and implements the best-in-class cardiovascular Magnetic Resonance Imaging solutions. At the heart of everything we do is our unrelenting drive to continually offer better solutions for healthcare providers that improve healthcare outcomes. This fuels our creativity, informs our decisions and it is the reason we are passionate about our work and most importantly why we are successful. We are careful stewards of resources focused on optimizing both customer and investor value. We strive to make Circle a place where employees are highly valued, engaged, and have opportunities for professional development. Our roots are medical and digital, our passion is contagious, and our people are amongst the best.

Position Overview:
Reporting to the Director of Regulatory Affairs and Quality Management System (QMS), the QMS
Analyst is responsible for maintaining and improving the Quality Management System for Circle
Cardiovascular Imaging Inc. In this position, the QMS Analyst will work closely with the Director
of RA/QMS as well as others in the team/company to continuously improve and manage the
company’s QMS activities including related compliance activities.

General Responsibilities:

• Maintain and improve the already established Quality System, assuring company
  compliance to requirements of 21 CFR Part 820, ISO 13485:2016, European Medical
  Device Regulations, Canadian Medical Device Regulations and other applicable
  international standards and regulations including the jurisdictions covered by MDSAP
  program and beyond.
• Review the requirements for new or revised applicable standards/regulations and
  implement them as a part of the QMS
• Provide training to employees on the regulatory requirements, standards, regulations and
  QMS as applicable
• When required, represent company at all the quality system and regulatory affairs related
  audits/inspections by ISO registrar/EU Notified Body, Regulatory agency, customers or any
  other relevant parties
• Assist in preparation and compilation of submission dossiers
• Preparing necessary documents for Management Review and maintaining Management
  review records
• Carry-out necessary statistical data collection, measurement and analysis, and reporting
  summaries for the management as required
• Maintaining the Corrective and Preventive actions program related activities effectively
• Maintaining the document control program effectively
• Maintaining the Internal audit program effectively
• Maintaining other relevant QMS documents such as deviations, non-conformance reports,
  effectively
• Compilation and maintenance of the Design Documentation as per Circle’s design control
  procedures
• Compilation and maintenance of the product Technical Documentation as required by
  relevant regulatory and standards requirements
• Assist with running the internal audit program effectively
• Assist the finance team in vendor/subcontractor review, approval, and audits when
  required
• Any other duties as required for the job function

Required Skills/Experience:

• A bachelor’s degree or master’s degree in biomedical engineering or relevant sciences
• Excellent technical writing skills
• Detail oriented and analytical skills
• Excellent communication skills both verbal and in writing
• Creative and Collaborative attitude

Beneficial Skills/Experience:

• Experience in medical device quality system complying to ISO 13485 and/or US FDA
• Quality System Regulation
• Formal training or education on Quality Management System or Internal auditor experience
• Prior experience with a medical device company with software applications
• Project management experience

Educational Requirements:

• Bachelor’s or Master’s degree in biomedical engineering or relevant sciences

About the benefits 

• Competitive compensation

• Paid personal time off

• Comprehensive health benefits on day one

• RRSP matching program

• Flexible working arrangements

• Employee Wellness Program

• Professional development and tuition reimbursement program

• Gratifying internal recognition/kudos programs

• Annual salary review – based on company and individual performance

• A fun, inclusive, ego-free environment where diversity and individual thoughts are encouraged and valued

• Company/team building events

Upon joining Circle CVI, you will be welcomed into a collaborative and supportive company with uncompromising values on quality, innovation, culture, and customer service. Join us in changing the medical technology world and submit your application below!