Careers
Company Overview
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.
Job Overview
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.
Job 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)
Salary and Benefits
- $40,000.00 - $45,000.00 CAD annually - pay commensurate to experience.
Benefits
- Dental care
- Disability insurance
- Extended health care
- On-site parking
Schedule:
- Monday to Friday
Required Skills/Qualifications
- 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
Application
To apply, submit your resume and a cover letter explaining your interest and qualifications for the role to careers@btnx.com. For questions about the application process, please contact careers@btnx.com. We look forward to learning more about how you can contribute to our team.
AI will be used as part of the applicant screening process.
Company Overview
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 advanced in-vitro diagnostic (IVD) tests for laboratories, clinics, hospitals and physician offices. Headquartered in Pickering, ON, BTNX’s core business operations are within Canada & USA, with international sales spanning dozens of countries around the globe. BTNX distributes its products under the Rapid Response® brand and is a certified Original Equipment Manufacturer (OEM) of rapid diagnostic tests.
Position Summary
We are looking for a highly organized and adaptable individual to support daily operations and business development activities. This role works across departments to help keep projects on track, support internal processes, and assist with coordination between teams.
Responsibilities (basic & flexible)
- Support day-to-day operational tasks as needed across multiple departments
- Assist with project coordination and follow-up on action items
- Help maintain organization and workflow in shared spaces (e.g., warehouse or office)
- Communicate with internal teams and external partners as directed
- Provide administrative and logistical support for meetings, calls, and customer touchpoints
- Take on additional duties as the role evolves based on business needs
Required Skills & Qualifications
- Bachelor’s degree in a related field (e.g., biosciences, business, or equivalent experience)
- Results-oriented with strong business savvy skills
- Highly organized and able to multitask
- Strong written and verbal communication skills
- Adaptable to change and comfortable with a non-repetitive workday
- Problem-solving mindset with attention to detail
Salary
Pay commensurate to experience. Expected range $40,000-$50,000 annually.
Application
To apply, submit your resume and a cover letter explaining your interest and qualifications for the role to careers@btnx.com. For questions about the application process, please contact careers@btnx.com. We look forward to learning more about how you can contribute to our team.
Company Overview
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 70+ of countries. Headquartered in Pickering, ON, BTNX offers an exciting opportunity for a motivated individual to join our team.
As we continue to expand our product portfolio and global reach, we are seeking a technically minded and entrepreneurial professional to join our growing commercial operations team.
Job Overview
This role bridges technical product knowledge and client engagement, offering an excellent entry point into the business side of biotechnology. As a Technical Sales Associate, you will gain in-depth understanding of our diagnostic technologies, including assay sensitivity, specificity, and cross-reactivity, and use that knowledge to support, educate, and retain key customers.
You will collaborate closely with Sales, Product Development, and Quality Assurance teams to provide informed, science-based solutions to client needs, while also contributing to the continuous improvement of BTNX’s products and customer experience.
Responsibilities
- Serve as a primary liaison between customers and internal teams, combining technical expertise with service excellence.
- Process customer orders received via phone and email, ensuring accuracy and timely fulfillment.
- Manage customer accounts, engaging clients to resolve issues, strengthen relationships, and recover delayed accounts.
- Communicate scientific and technical details clearly and confidently, including assay performance, cross-reactivity data, detection limits, and storage/handling parameters.
- Assist with receiving and processing customer complaints according to standard operating procedures for medical devices
- Support the Sales and QA teams in addressing customer inquiries, product feedback, and post-market data requests.
- Work closely with Operations, Regulatory Affairs, Quality, and Logistics to ensure seamless customer support.
- Document all communications and maintain accurate CRM records.
- Provide regular updates to senior management on customer insights, sales trends, and product feedback.
- Contribute to ad hoc business development projects, product education initiatives, and marketing efforts as assigned.
- Track and coordinate customer returns and maintain return records.
Qualifications
- REQUIRED: Bachelor's degree in biology, Biomedical Engineering, Biology, Biochemistry, Biomedical Sciences, Life Sciences or related field
- PREFERRED: 0-2 years’ experience in customer service
- Excellent oral and written communication skills.
- Flexible, with the ability to adapt easily to change, think logically, and effectively solve problems communicate clearly, effectively, and professionally, and follow process documentation closely.
- Strong analytical skills, with the ability to interpret business needs into actionable items.
- Very strong initiative with a drive to proactively take on tasks and find solutions.
- Excellent creativity & resourcefulness
- Highly organized and capable of efficiently multi-tasking.
- Detail and results oriented.
- Able to work independently and as a team to complete tasks within deadlines.
- Advanced proficiency in MS Outlook.
Compensation
Pay commensurate to experience, anticipated range $40,000-50,000CAD.
Application
To apply, submit your resume and a cover letter explaining your interest and qualifications for the role to careers@btnx.com. For questions about the application process, please contact careers@btnx.com. We look forward to learning more about how you can contribute to our team.
Scientist I
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 70+ of countries. Headquartered in Pickering, ON, BTNX offers an exciting opportunity for a motivated individual to join our team.
As we continue to expand our product portfolio and global reach, we are seeking a technically minded scientist to help us continue to develop and enhance our line of quality diagnostic products.
Job Overview
The position of Scientist I is an integral part of the BTNX Inc. team. The Scientist I will support laboratory testing, R&D activities, product performance studies, and technical documentation. Successful candidates will be detail-oriented, scientifically curious, and able to execute laboratory work independently while maintaining accurate records and communicating results clearly.
Responsibilities
- Perform laboratory testing to support product development, quality control, verification, validation, and investigation activities
- Support R&D projects, including experiment planning, sample preparation, assay execution, data collection, and result analysis
- Conduct performance studies on medical devices and diagnostic products under established protocols
- Assist with method development, troubleshooting, optimization, and evaluation of laboratory procedures
- Prepare reagents, buffers, samples, and testing materials according to Standard Operating Procedures (SOPs) and study requirements
- Maintain accurate laboratory records, raw data, worksheets, and technical documentation in accordance with good documentation practices
- Prepare and review technical documents, such as study protocols, reports, summaries, product inserts, technical files, and presentations
- Review certificates of analysis, quality control reports, testing records, and other technical documents as required
- Support medical device complaint investigations and technical evaluations in coordination with Quality Assurance and Regulatory Affairs department
- Support proficiency testing, value assignment, and other technical support activities as required
- Maintain laboratory organization, equipment readiness, and compliance with applicable safety and quality procedures
- Develop or support training materials related to laboratory testing and product performance
- Perform other related duties assigned by management
Qualifications
- Bachelor's Degree or MSc (preferred) in chemistry, biochemistry, biology, biotechnology, medical laboratory science, or a related scientific field
- 0-3 years' experience in biotechnology, medical device, pharmaceutical, diagnostic, or related laboratory setting
- Strong scientific background with hands-on laboratory testing experience
- Basic wet chemistry and laboratory skills such as weighing, measurements, solution preparation, dilutions, sample preparation, and routine testing
- Familiarity with assay development, analytical testing, quality control testing, or R&D experimentation is an asset
- Must be able to work independently and effectively to coordinate multiple tasks and changing priorities
- Strong critical thinking, troubleshooting, and problem solving skills
- High attention to detail and strong documentation practices
- Strong communication skills (both oral and written)
Compensation
Pay commensurate to experience, anticipated range $45,000-50,000CAD.
Please note, this position is full time and does not include a hybrid office. Selected candidate must be able to commute to our office in Pickering, Ontario daily.
Application
To apply, submit your resume and a cover letter explaining your interest and qualifications for the role to careers@btnx.com. For questions about the application process, please contact careers@btnx.com. We look forward to learning more about how you can contribute to our team.
Canada