Ensure compliance and product excellence with MIMOSA Diagnostics as a Senior Quality Assurance and Regulatory Affairs Specialist. Work hybrid from Toronto to drive improvements in quality standards.
MIMOSA is committed to compassionate care through creative solutions and seeks a Senior Quality Assurance/Regulatory Affairs Specialist. This role plays a crucial part in maintaining compliance with regulatory standards governing medical devices. A deep understanding of quality management systems in the medical industry is essential for facilitating audits and collaboration on quality issues.
Key Responsibilities
- Develop quality assurance strategies to meet compliance needs
- Perform internal audits and regulatory inspections
- Prepare regulatory documentation for Health Canada and FDA
- Address regulatory compliance issues with cross-functional teams
- Lead product quality investigations and corrective actions
Requirements
- Bachelor’s degree in Science or Engineering
- At least 3 years in quality assurance, medical devices preferred
- In-depth knowledge of ISO 13485:2016 and regulations
- Strong communication and analytical capabilities
- Certification in quality assurance is beneficial
Contribute to MIMOSA’s mission of empowering quality healthcare by ensuring compliance and excellence in product offerings.