Quality Assurance and Regulatory Affairs Associate

Job Title: Quality Assurance and Regulatory Affairs Associate Full-time

Company: BTNX Inc.

Location: 722 Rosebank Road, Pickering, Ontario

BTNX 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.

The 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.

• Ensuring Senior Management is up to date on medical device regulatory requirements, and ensure required changes or updates are implemented
• Ensuring all facility and product registrations are current i.e. Health Canada, FDA, CE mark
• Assist in preparation of documents and submission for FDA, Health Canada, EU, and other international product registration
• Involved in updating and maintaining of BTNX’s ISO 13485 QMS
• Involved in Internal audit process and to coordinate external audits
• Document Control: Creation, revision, review, approval, and control of documents
• Review of complaint files, Nonconformity Documentation forms, and corrective/preventative actions
• Risk management as determined in meeting all applicable regulatory requirements
• Review and approval of content for Product Labeling
• Recalls and medical device reporting
• Assist in organization of Management Review meeting(s)

• Bachelor’s or master’s degree or equivalent in Regulatory Affairs, Medical Science, Life Science or another relevant field
• 0 to 2 years of relevant experience (or demonstrated abilities)
• Strong Organizational and Multi-Tasking Skills
• Recognized Degree in Relevant Field
• Regulatory Affairs knowledge (strongly preferred)
• Quality Systems knowledge (preferred)
• Experience in FDA or Health Canada, and/or European in-vitro diagnostic medical device regulations
• Excellent communication skills, including written, oral, and phone

Department:
Quality Assurance and Regulatory Affairs

• Pay commensurate to experience.

Benefits

• Dental care
• Disability insurance
• Extended health care
• On-site parking

Schedule:

• Monday to Friday

To apply, submit your resume and a cover letter explaining your interest and qualifications for the role to [email protected] along with answers to the below questions. For questions about the application process, please contact [email protected]. We look forward to learning more about how you can contribute to our team.

• Do you have any experience handling medical device or IVD related regulatory applications? If Yes, what class and which jurisdiction?

• Do you have any experience with creating (or handling) SOPs and Work Instructions in a medical device QMS?