Regulatory Software Assurance Specialist

3 weeks ago


Mississauga, Ontario, Canada Vitalbio Full time

We are Vitalbio, a leading provider of in-vitro diagnostic solutions. As a Regulatory Software Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our software products.

About the Role

This position requires an individual with experience in software quality assurance for regulated medical devices. The ideal candidate will have a strong understanding of key QMS processes like Design Control, Document Control, Change Control, etc.

The successful candidate will be responsible for designing and executing test strategies to identify issues early and improve our quality processes. They will also manage documentation and tracking to ensure comprehensive records of test results, defects, and resolutions.

This is a challenging opportunity for someone who wants to make a real impact on the quality of our software products.

Key Responsibilities:

  • Develop and execute software quality assurance plans, including validation plans, test protocols, and risk assessments.
  • Create and maintain software requirements documents (SRS/SDS) and risk analysis documents.
  • Establish traceability between identified risks, mitigations, verifications, and validations.
  • Manage Computer Software Assurance (CSA) activities for all non-product software systems and internal tools.
  • Support external software testing initiatives and perform audits and assessments of third-party vendors.

Requirements:

  • Experience in software quality assurance for regulated medical devices.
  • Strong understanding of key QMS processes like Design Control, Document Control, Change Control, etc.
  • Knowledge of FDA 21 CFR part 820, ISO 13485, and ISO 62304 regulations.
  • Familiarity with issue tracking tools like Jira.
  • Good communication skills and the ability to collaborate with a team.

What We Offer:

  • A competitive salary of $120,000 - $150,000 per year, depending on experience.
  • A dynamic and supportive work environment.


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