Senior Quality Assurance/Regulatory Affairs Specialist

at  MIMOSA Diagnostics

POSITION

We are dedicated to providing exceptional products and services to our customers, and we are seeking a Senior Quality Assurance/Regulatory Affairs Specialist to join our team. As the Senior Quality Assurance/Regulatory Affairs Specialist, you will play a crucial role in supporting the Quality Assurance and Regulatory Affairs processes at MIMOSA, driving the success of our products. This role will be responsible for ensuring that our products comply with regulatory requirements and quality standards, and will involve developing, implementing, and maintaining quality assurance processes, conducting audits, and providing guidance on regulatory affairs. The ideal candidate will have a strong background in quality management systems and regulatory compliance within the medical device industry in Canada and the US.

REQUIRED SKILLS AND EXPERIENCE

• 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.
• Experience and understanding of regulations in the EU and other jurisdictions, specifically MDD/MDR is an asset
  Note: This job description serves as a general overview of the responsibilities and requirements for the position. Additional duties may be assigned as needed to meet business objectives.

• Develop and implement quality assurance strategies and regulatory compliance programs in line with the 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, including complaints, submissions, and reporting.
• Assess regulatory needs of the company, including researching standards for compliance and identifying how to meet the requirements of applicable regulatory authorities for the development and sale of medical devices in different markets.
• Ensure Marketing Authorization and Organization Registration with regulatory authorities are established and maintained as per applicable regulatory requirement and devices are sold in authorized regions only.