Senior Quality Assurance and Regulatory Affairs Specialist

4 weeks ago

Toronto, Ontario, Canada Mimosa Diagnostics Full time
About the Role

Mimosa Diagnostics is seeking a highly skilled Senior Quality Assurance and Regulatory Affairs Specialist to join our team. As a key member of our quality assurance and regulatory affairs team, you will play a crucial role in ensuring the success of our products by developing, implementing, and maintaining quality assurance processes, conducting audits, and providing guidance on regulatory affairs.

Key Responsibilities
  • Develop and implement quality assurance strategies and regulatory compliance programs in line with our established Quality Management System.
  • Conduct internal audits, inspections, and periodic quality monitoring to ensure adherence to quality standards and regulatory requirements.
  • Prepare and submit regulatory documents to appropriate agencies.
  • Collaborate with cross-functional teams to address quality and regulatory issues.
  • Monitor and analyze changes in regulations and industry standards to ensure ongoing compliance.
  • Provide training and support to staff on quality assurance and regulatory affairs best practices.
  • Review and approve validation protocols, change controls, and deviation reports.
  • Lead investigations related to product quality issues and implement corrective actions.
  • Maintain and update quality documentation, including SOPs, work instructions, and quality manuals.
  • Serve as the main point of contact for regulatory agencies, including Health Canada and the United States FDA, and manage communications effectively.
Requirements
  • Bachelor's degree in Science, Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 3 years of experience in quality assurance and regulatory affairs, preferably in the medical device industry, with a proven ability to facilitate the processes used to design, develop, validate, implement, monitor, control, and continuously improve, a Quality Management System within a regulated environment.
  • In-depth knowledge of regulatory requirements (e.g., FDA, ISO, etc.), Medical Device Single Audit Program (MDSAP), quality management systems, and quality standards, particularly ISO 13485:2016 and 21 CFR 820.
  • Experience with preparation and approval of regulatory submissions for medical devices to a major regulatory authority (e.g. Health Canada, FDA).
  • Proven experience in conducting audits and inspections.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Manage and control documents in an electronic quality management system.
  • Certification in quality assurance or regulatory affairs (e.g., ASQ, RAC) is a plus.
What We Offer

Mimosa Diagnostics provides its employees with the perfect balance of autonomy and support, and we always welcome feedback. We offer a comprehensive benefits program, discretionary time off with mandatory minimums, MIMOSA Days, flexible working hours, and a hybrid role based in Toronto.

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