QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSOCIATE

Position: QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSOCIATE

Type: Full-time

Experience: 2 or more years of relevant experience (or demonstrated abilities)

Location: Pickering, Ontario. (on-site)

Job Description:

The QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSOCIATE is responsible for the up keeping 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 to 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 Requirements:

• 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

Responsibilities:

• 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)

About Us: Located in Pickering, Ontario, BTNX Inc. (BTNX) is a biotechnology company and a world leader in rapid, point-of-care diagnostics. We specialize in innovation, research, development, and manufacturing of rapid diagnostic tests and associated IT solutions for laboratories, clinics, hospitals, and physician offices. We offer a broad product catalog that includes tests for infectious diseases, drug screening, pregnancy and much more. Headquartered at our new facility in Pickering, ON, BTNX’s core business operations are within Canada & USA, with international sales spanning over 135 countries around the globe. BTNX. distributes its products under the Rapid Response® brand.

We are a company that values dedication, resourcefulness, ownership, and results, and look to foster the entrepreneurial spirit in all our talent.

BTNX Offers a flexible work schedule for a better work/life balance, paid vacation, health and dental benefits, causal dress, team gatherings and celebrations, career growth, onsite parking, and much more.

BTNX is not only a certified member of the Canadian Aboriginal and Minority Supplier Council we are also an equal opportunity employer. We believe in a diverse workplace, we encourage and are pleased to consider all applicants regardless of race, color, creed, religion, sex, material/family status, sexual orientation, gender identity, national origin, veteran, or disability status.