Job Details
  • Position: Quality Assurance & Regulatory Affairs Associate
  • Function: Technical
  • Duration: Full Time
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 Markham, ON, BTNX’s core business operations are within Canada & USA, with international sales spanning dozens of countries around the globe.

Role Overview

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 ISO 13485:2016.

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 product registration
  • Updates and maintenance of BTNX’s ISO 13485 QMS
  • 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)
Required Skills & Qualifications
  • 1 or more years of relevant experience (or demonstrated abilities)
  • Strong Organizational and Multi-Tasking Skills
  • Recognized Degree in Relevant Field
  • Strong knowledge of, and experience working with, ISO 13485:2016
  • Regulatory Affairs knowledge (strongly preferred)
  • Quality Systems knowledge (strongly preferred)
  • Internal Audit training (preferred)
  • Knowledge in FDA, Health Canada, and European in-vitro diagnostic medical device regulations
  • General level of computer proficiency
  • Excellent communication skills, including written, oral, and phone
Application and Details

We are a company that values dedication, resourcefulness and results, and look to foster the entrepreneurial spirit in all our talent. If this is something that speaks to you, please provide your CV and cover letter today to careers@btnx.com!

Job Details
  • Position: Customer Retention & Sales Analyst
  • Function: Business Development
  • Duration: Full Time
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 Markham, ON, BTNX’s core business operations are within Canada & USA, with international sales spanning dozens of countries around the globe.

Role Overview

The Customer Retention & Sales Analyst will be responsible for the creation and implementation of customer retention strategies. The primary emphasis will be on a proactive approach, though both reactive and lost customer win-back strategies will also be utilized. This position is responsible for the development of the process right through implementation with direct responsibility for customer retention KPIs. This role will work closely with the Sales and Customer Service departments, as well as various other departments (IT, Operations, Marketing, etc.). This position offers the candidate a holistic view of the business, with direct participation in key decisions with senior management. A successful candidate will be someone with strong business acumen, excellent communication skills, analytical skills and inquisitiveness. This role will be reporting directly to the BTNX’s CFO.

Required Skills & Qualifications
  • Minimum: College or University Degree
  • Oral & Written fluency in English
  • Experience: Minimum 3 years in a business analyst function with some project management responsibilities
  • Preferred: 5+ years with direct experience in project management and analytics pertaining to client retention
  • Strong analytical skills and attention to detail
  • Well organized and able to work under minimal supervision
  • Strong interpersonal communication & selling skills
  • Resourcefulness & ability to multitask
Application and Details

We are a company that values dedication, resourcefulness and results, and look to foster the entrepreneurial spirit in all our talent. If this is something that speaks to you, please provide your CV and cover letter today to careers@btnx.com!