Experience

1 or more years of relevant experience (or demonstrated abilities)

Job Requirements
  • Strong Organizational and Multi-Tasking Skills
  • Recognized Degree in Relevant Field
  • 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
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)
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.

Please send your resume and cover letter to careers@btnx.com

Education and Qualifications
  • Current co-op student within a university in Ontario
  • Recently graduated student having completed their undergraduate degree, preferably Honors Bachelor of Science
Responsibilities
  • Receives, processes and verifies the accuracy of orders from customers utilizing the organization’s internal systems and customer purchase orders
  • Initiates required action for response to customer service requests for order changes, including the maintenance of order and communicates changes to the appropriate personnel/departments
  • Resolve problems, facilitate solutions and enhance customer service offerings
  • Provide back-up support to coworkers in the performance of job duties required
  • Answers customer inquiries/communications as required
  • Oversee assigned projects from initiation to completion; setting timelines and targets to ensure the projects progress in a timely manner
  • Communication with senior management for regular updates regarding project statuses
  • Documenting and prioritizing tasks, in consultation with management
  • Develop international customer and distributor relations
  • Ad hoc projects that arise in the regular course of business
  • Become familiar with proposed new product; its function, purpose, and value to end-users
  • Conduct analysis to determine best implementation procedure for product into clinics and laboratories
  • Performs other related duties assigned by management
Job Requirements
  • Project management skills & business acumen
  • Strong analytical skills, being able to interpret business needs into actionable items
  • Very strong initiative
  • Excellent creativity & resourcefulness
  • Organized and ability to multi-task
  • Detail and results-oriented
  • Strong time management skills
  • Motivated individual who thrive in ambiguous situations
  • Superior written and verbal communication skills
  • Able to work independently and as a team to complete tasks within deadlines
  • High proficiency in MS Outlook
Application and Details

Do you have what it takes? Tell us why you are awesome and why you want to work for BTNX Inc. by submitting your resume and cover letter to careers@btnx.com. We can’t wait to hear from you!