Regulatory Affairs & Quality Assurance Associate

Location: Toronto, Ontario, Canada (Local hires only)

Job Description

Duties & Responsibilities:

As the Regulatory Affairs & Quality Assurance Associate, you will understand, evaluate the quality & regulatory requirements under the European, US FDA & Health Canada Medical Device (IVD) Regulations. You will develop strategic submission plans and prepare technical documentations to meet with various regulatory body requirements. You will also provide support to maintain the company’s quality system as per ISO 13485 requirements.

  • Coordinate with all departments of the company to prepare technical documentations for regulatory submissions.
  • Develop effective working relationships with suppliers and partners to support regulatory strategies.
  • Collaborate with sales & marketing team to evaluate and prioritize device submissions
  • Recommends strategies to ensure timely approvals of device applications.
  • Liaise with business development and manufacturing teams to ensure proper expansion and development of procedures.
  • Review product labeling as per regulatory requirements
  • Ensure all regulatory and quality documents are properly maintained.
  • Keeps abreast of regulatory updates & changes.
  • Assist in the maintenance of company’s current quality system.

Requirements:

  • Bachelor’s degree in science or health discipline or a graduate of community college program in a related field.
  • Postgraduate certificate in Regulatory Affairs and/or Quality Assurance is an asset.
  • Minimum 2 years of experience within the medical device industry.
  • Working knowledge of US FDA, Health Canada, European MD/ IVD requirements
  • Working knowledge of the ISO 13485 Quality System requirements.
  • Strong analytical skills
  • Ability to interpret and organize scientific data.
  • Strong comprehension and scientific writing skills
  • Ability to interpret and understand regulations in the context of the scientific and commercial environment
  • Detail oriented
  • Proficient in using computer software such as Microsoft Word, Excel, PDF, etc.

If interested, please send your CV to ra.qa@td-diagnostics.ca and finance@td-diagnostics.ca. We will get back to you at the earliest!!

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