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open positions for our office in
Edmonton
position
Regulatory Affairs Manager
qualifications
A minimum of 5 years of experience in medical device quality assurance and regulatory affairs
A University Degree in a Science or Engineering field; a related Diploma with demonstrable hands-on experience will also be considered.
Strong attention to detail, coupled with the ability to distill these details and communicate effectively with teammates (in both software-quality and business-development aspects)
Direct experience with regulatory submissions - and corresponding regulations and laws - in the U.S. (510k, DeNovo, CFR QSR) and Europe (CE-marking, MDD and MDR). Experience working with regulatory agencies in the Asia-Pacific region is also an asset.
Proficiency with using, maintaining, and auditing electronic Quality Management Systems in accordance with ISO 13485
Experience with ongoing development and maintenance of medical device documentation
Demonstrable knowledge of risk management standards and processes (ISO 14971)
Experience with medical device security and software cybersecurity standards is a definite asset
Relevant experience outside of the Regulatory Assurance field (ie: software development, quality assurance, image analysis, artificial intelligence systems) is highly desirable
Previous startup experience and the ability to “wear multiple hats” at times is a definite asset
You are a self-starter with a strong sense of urgency, who is always happy to take initiative and learn more!
A minimum of 2 years of direct experience in software development and/or software testing
A University Degree in Computing Science or a related field, and/or substantial demonstrable hands-on experience (portfolio)
Strong attention to detail: you are meticulous and thorough in your design and execution of test plans
Persistence and creativity: you are always looking for new ways to make software more durable and efficient, and also to streamline the workflows of fellow developers and testers
Excellent time management skills
Experience with testing C# and Javascript/Typescript, ideally as part of front-end and back-end web frameworks (MVC.NET, Razor, Angular, React)
Experience with whitebox and blackbox testing techniques, at the unit, system, and user-acceptance levels
Some experience with generating and maintaining code-level and long-form documentation
Some experience with using automated systems and frameworks to streamline development and testing
Experience with testing containerized systems and cloud architectures is a definite asset
Cybersecurity testing skills are a definite asset
Experience with the DICOM protocol is an asset
Relevant experience outside of the Software Development field (ie: Quality Assurance, DevOps, image analysis and visualization techniques, artificial intelligence systems) is an asset
Previous startup experience and the ability to “wear multiple hats” at times is a huge plus
You are a team player with exceptional verbal and written communication skills
You take pride in the quality of your work and in the mastery of subject matter
You are a self-starter who is always happy to take initiative and learn more!
A minimum of 5 years of direct experience in software development and/or software testing
A University Degree in Computing Science or a related field, and/or substantial demonstrable hands-on experience (portfolio).
Strong attention to detail: you are meticulous and thorough in your design and execution of test plans at a range of structural levels
Persistence and creativity: you are always looking for new ways to make software more durable and efficient, and also to streamline the workflows of fellow developers and testers
Excellent time management skills
Ample experience with testing front-end and back-end web frameworks (MVC.NET, Angular, React) as well as standalone program code (C#, JS, Typescript, Python)
Some experience with generating and maintaining code-level and long-form documentation
Experience with building and leveraging automated systems and frameworks to streamline software development and testing procedures
Experience with whitebox and blackbox testing techniques, at the unit, system, and user-acceptance levels
Experience with testing containerized systems and cloud architectures is a definite asset
Cybersecurity testing experience is a definite asset
Experience with the DICOM protocol is an asset
Relevant experience outside of the Software Development/QA fields (ie: DevOps, image analysis and visualization techniques, artificial intelligence systems) is an asset
Previous startup experience and the ability to “wear multiple hats” at times is a huge plus
You are a team player with exceptional verbal and written communication skills
You take pride in the quality of your work and in the mastery of subject matter
You are a self-starter who is always happy to take initiative and learn more!
A minimum of 5 years of direct experience in software development
A University Degree in Computing Science or a related field, and/or substantial demonstrable hands-on experience (portfolio).
Direct experience working with software products that fit into the medical imaging workflow - ie. DICOM, PACS, etc standards
Strong attention to detail: you are meticulous and thorough in your design and execution of test plans at a range of structural levels
Persistence and creativity: you are always looking for new ways to make software more durable and efficient, and also to streamline the workflows of fellow developers and testers
Excellent time management skills
Being eager to learn, self-motivated and passionate
Knowing and understanding the concepts of Object Oriented Design and Development
Strong experience in Microsoft .Net framework programming
Strong understanding of various database designs, storage management, and cloud computing architectures such as GCP, Kubernetes
Experience with continuous integration / continuous deployment
Experience with different front-end development technologies
Strong understanding of code versioning tools, such as Git
You are a team player with exceptional verbal and written communication skills
You take pride in the quality of your work and in the mastery of subject matter
You are a self-starter who is always happy to take initiative and learn more!
