Quality Assurance and Regulatory Affairs Associate - Entry LevelJob Title:Quality Assurance and Regulatory Affairs Associate - Entry LevelDepartment:Quality Assurance and Regulatory AffairsEmployment Type:Full‑timeLocation:722 Rosebank Road, Pickering, OntarioCompany OverviewBTNX Inc. (BTNX) is a leading biotechnology company specializing in rapid, point‑of‑care diagnostics. As a pioneer in the field, we are dedicated to innovation, research, and the development of advanced in‑vitro diagnostic (IVD) tests. Our operations extend across laboratories, clinics, hospitals, and physician offices, with our core business presence in Canada & USA as well as a global presence spanning dozens of countries. Headquartered in Pickering, ON, BTNX offers an exciting opportunity for a motivated individual to join our team.Job OverviewThe Quality Assurance and Regulatory Affairs Associate is responsible for the upkeeping and monitoring of the Quality System, to ensure its effective use and functionality. This position requires the development of an in‑depth knowledge of all facets of the company and of the various regulations and quality systems of which BTNX Inc. may be a part. The Quality Assurance and Regulatory Affairs Associate is responsible for all the tasks outlined by the pertinent regulations, which include the ISO13485:2016, US FDA QSR, IVDR, Health Canada MDR.Job ResponsibilitiesEnsuring Senior Management is up to date on medical device regulatory requirements,



and ensure required changes or updates are implementedEnsuring all facility and product registrations are current i.E. Health Canada, FDA, CE markAssist in preparation of documents and submission for FDA, Health Canada, EU, and other international product registrationInvolved in updating and maintaining of BTNX’s ISO 13485 QMSInvolved in Internal audit process and to coordinate external auditsDocument Control: Creation, revision, review, approval, and control of documentsReview of complaint files, Nonconformity Documentation forms, and corrective/preventative actionsRisk management as determined in meeting all applicable regulatory requirementsReview and approval of content for Product LabelingRecalls and medical device reportingAssist in organization of Management Review meeting(s)Salary and Perks$40,000.00 - $45,000.00 CAD annually - pay commensurate to experience.BenefitsDental careDisability insuranceExtended health careOn‑site parkingScheduleMonday to FridayRequired Skills/QualificationsBachelor’s or master’s degree or equivalent in Regulatory Affairs, Medical Science, Life Science or another relevant field0 to 2 years of relevant experience (or demonstrated abilities)Strong Organizational and Multi‑Tasking SkillsRecognized Degree in Relevant FieldRegulatory Affairs knowledge (strongly preferred)Quality Systems knowledge (preferred)Experience in FDA or Health Canada, and/or European in‑vitro diagnostic medical device regulationsExcellent communication skills, including written, oral, and phone#J-18808-Ljbffr

📌 Quality Assurance And Regulatory Affairs Associate - Entry Level - C$40,000 - C$45,000 A Year (Winnipeg)
🏢 BTNX
📍 Winnipeg