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 RA/QMS Analyst is responsible for maintaining and improving Regulatory compliance, and the Quality Management System, for Circle Cardiovascular Imaging Inc. In this position, the RA/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 compliance of the company’s established QMS as well as continually expand and maintain current regulatory clearances and approvals.
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.
- Lead, and support, preparation and compilation of submission dossiers globally.
- Lead, and support, effective communication with Circle’s external service provider(s)
- 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.
- Preparing necessary documents for Management Review and maintaining Management review records.
- Preparing necessary documents for regulatory compliance including but not limited to: PMS, PMCF, PSUR, annual reporting.
- Carry-out necessary statistical data collection, measurement and analysis, and reporting summaries for 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 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 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 Management System Regulation.
- Formal training or education on Quality Management Systems, auditor experience, etc.
- Prior experience with a medical device company with software applications.
- Project management experience.
Educational Requirements:
- Bachelor’s or master’s degree in 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!
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Circle Cardiovascular Imaging Calgary, Alberta, CAN Office
Suite 1800, 707 - 8th Ave SW, 1800, Calgary, Alberta, Canada, T2P 1H5
