Regulatory Affairs Specialist

2 weeks ago

Calgary, Canada Circle Cardiovascular Imaging Full time

Do you want to join a diverse and global team that is revolutionizing the cardiovascular healthcare industry? Circle CVI is hiring

**About Circle Cardiovascular Imaging**

Circle Cardiovascular Imaging Inc. (Circle CVI) is revolutionizing the medical technology industry by developing world-class and advanced post-processing solutions for cardiovascular and neurovascular imaging. Headquartered in Calgary and with offices in Germany, the Netherlands, China, and the USA, Circle CVI is a global leader in serving over 1000 hospitals in over 50 countries.

Founded in 2007, Circle CVI has partnered with some of the most respected bodies in the medical field to disrupt and innovate cardiovascular and neurovascular imaging using machine learning, big data, AI, and other technologies. Our proprietary technology successfully demonstrates our capabilities within the same range as expert human readers, improving cardiovascular health through excellence in imaging as an integral part of precision medicine.

In early 2021, we have received a significant investment from the Canadian government’s Western Diversification Program (WDP) as recognition for our position “as the world leader in cardiovascular imaging.” With the highest priority in excellence, our products and services are truly changing the world, allowing healthcare providers to give more precise care to patients.

Currently, Circle CVI is looking for a **Regulatory Affairs Specialist** to join our team in a full-time hybrid work model (remote and in office) in our headquarters in **Calgary, Alberta (or other location).**

Reporting to the Regulatory Affairs Lead (RA Lead), the Regulatory Affairs Specialist (RA Specialist) is responsible for maintaining and improving regulatory compliance activities for Circle Cardiovascular Imagining Inc. In this position, the RA Specialist will work closely with the RA Lead as well as others in the company to continuously execute, improve, and manage the company’s regulatory compliance activities as well as certain Quality Management System (QMS) activities as a member of the RA/QMS Department.

**About the Opportunity**

As our new **Regulatory Affairs Specialist**, you will:

- Ensure compliance to requirements of 21 CFR Part 820, ISO 13485, the European Medical Device Regulation, the Canadian Medical Device Regulation, and other applicable international regulations and standards, including jurisdictions covered by MDSAP
- Maintain and improve Circle’s already established Quality System
- Provide expertise in regulatory strategy, planning, and preparation of US FDA pre-subs and 510k submissions, and Health Canada Medical Device License Applications
- Prepare technical documentation/medical device files to meet EU MDD/MDR and other global requirements for applicable regulations and standards
- Prepare submission documentation for worldwide product approvals, registrations, and clearances
- Prepare regulatory-related documentation for Circle’s product distribution partners and other stakeholders
- Liaise with regulatory agencies and internal/external partners to manage regulatory submissions on behalf of Circle
- Assist the RA Lead in preparing regulatory reports for senior management on the status of pending regulatory submissions and current licenses/clearances
- Track and update relevant Key Performance Indicators (KPIs) to keep the RA/QMS department reporting current and accurate
- Assume regulatory process ownership by creating/updating quality guidelines and work instructions, as necessary
- Identify and implement continuous improvement initiatives
- Assist the RA Lead in monitoring markets for changes to applicable regulations and requirements, and communicating changes as needed across the organization
- Review promotional material and labeling for regulatory compliance
- Participate as part of the interdisciplinary whole product team to create, assemble, and maintain technical documentation including clinical evaluation plans/reports, post-market surveillance plans/reports, clinical follow up activities, and Periodic Safety Update Reports
- Facilitate and contribute to Circle’s product and process risk management activities
- Advise and provide training to employees on regulatory and QMS requirements
- Perform data collection, monitoring and measurement, statistical data analysis, and prepare report summaries on Circle’s products and processes for senior management
- When required, represent Circle at quality system-related and regulatory affairs-related audits and inspections by external bodies, such as the ISO registrar, Circle’s EU Notified Body, regulatory agencies, customers, distribution partners, or any other relevant parties
- When required, assist in vendor/subcontractor review, approval, and audits, by generating and providing supporting documentation
- Perform related duties as assigned, within your scope of practice

**About You**
- 2+ years of experience in a medical device regulatory-

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