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Regulatory Affairs Manager
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!