Required Regulatory Affairs and Quality Manager.
Develop and execute the company's regulatory strategy for its product pipeline.
Develop and maintain submissions to regulatory agencies required to allow The company's products to be sold in all regions and markets (FDA, CE, Health Canada).
Develop and maintain the The company's 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 The company's Quality Management System.
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.