Regulatory Affairs and Quality Manager

Position description:
• Develop and execute the company's regulatory strategy for its product pipeline.
• Develop and maintain submissions to regulatory agencies required to allo products to be sold in all regions and markets. (FDA, CE, Health Canada)
• Develop and maintain th Quality Management System and supporting procedures capable of meeting ISO 13485, ISO 63204, ISO 14971, as well as FDA (QSR), EU – Medical Device Regulation, and Health Canada (CAN-ISO 13485) requirements
• Manage auditing activities from the different regulatory agencies including Notified Bodies, FDA, Health Canada and other agencies.
• Monitor all of the software developing and testing activities (including their relevant documentations) to ensure adherence and conformity with Quality Management System.
• Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations.
• Maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications and submissions to regulatory agencies
• Develop quality system documentation (such as procedures and work instructions) to address new and updated standards and guidance’s, as required.
• Assist as required during clinical trials in accordance with rules mandated by regulatory agencies.
• Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
• Provide responses to regulatory agencies regarding product information or issues.
• Train staff in regulatory policies or procedures.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations as well as reporting to the regulatory authorities as needed.
Requirements:
• Formal post-secondary degree/diploma in regulatory affairs related to a Medical Device – required.
• Regulatory Affairs and Quality Assurance certifications – asset
• Strong understanding and hands-on experience (5+ years) with medical device software regulation and QA according to ISO 13485, ISO 62304, ISO 27000, MDR, GDPR, FDA (QSR) is required
• Proven track record of developing and managing quality management system that fits to medical device software development organization – required
• Proven track record of drafting and submission of pre-submissions, 510(k) applications to the FDA as well as submission of Technical File for review of Notified Body – required
• Experience with digital systems to ensure compliance of software development and commercial organization with quality management system – asset.