Senior Quality Assurance Affairs Analyst

  • Change Healthcare Canada Company
  • Richmond, British Columbia, Canada
  • May 23, 2022

Job Description

The Senior Quality Assurance and Regulatory Affairs Analyst role at Change Healthcare Canada Company supports the relevant activities to ensure that the Company's products and business processes comply with relevant medical device regulations.
  • Ensure that the Company's Quality System is compliant with the relevant medical device regulations in Canada, United States, Europe and Australia (and other markets the company decides to enter)
  • Mange Supplier Management Program to ensure that subject 3rd
    parties are meeting all relevant requirements, and comply with CHC
    qualification criteria
  • Provides subject matter expertise, interpretations and training on applicable medical device regulations
  • Provide necessary support for Quality Audits where necessary including
    internal audits, supplier audits, and external audits
  • Conducts medical device regulatory requirements research in the jurisdictions in which IWCS markets and plans to market its products
  • Provides summaries of the updated regulatory requirements landscape and providing access to associated current regulations and standards
  • Provides internal training on the relevant governing standards and regulations;
  • Proactively make recommendations and improves relevant quality assurance and regulatory affairs processes and procedures


Critical skills
  • Minimum 5 years of ISO 13485 quality systems and regulatory affairs experience in medical device industry, or equivalent
  • Experience in medical device development industry (software medical device experience preferred)
  • Working knowledge of medical device regulations in Canada, United States, European Union, UK, Australia
  • High quality of verbal, written and presentation skills and good problem solving/decision making capabilities required
  • Decisions are made under broad objectives. Have to be able to work independently with limited supervision


Additional Skills:
  • Ability to prioritize, multi-task and perform in a deadline-oriented environment
  • Proactive, collaborative and self-motivated and team player
  • Able to interact constructively with other departments, internal and external agencies, Notified body, auditors


Education:
  • Bachelor degree in Computer Science or Computer Engineering or related discipline
  • Diploma in Quality Management, Regulatory Affairs, or Operations Management
  • Other related education by training or by work experience RAPS certification preferred

Join our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system!

Some of our positions require employees to be onsite at a Change Healthcare facility or a Client site, including Medical Facilities. Depending on the site's health and safety guidelines, you may be required to have medical screenings or vaccinations to meet site requirements, which may include Covid-19 vaccination and/or testing. Further details and requirements will be confirmed during the interview process.