Responsibilities:

• Assist in the development and implementation of regulatory strategies for new medical device products or modifications to existing devices.
• Stay up to date with changes in regulations and standards that may impact the company's products.
• Prepare and submit regulatory applications, such as Health Canada License Dossiers, 510(k) submissions, and investigational device exemptions (IDEs) to regulatory authorities like the Health Canada, FDA (U.S.) or the EU (Europe).
• Prepare and submit regulatory reports and updates to regulatory authorities as required.
• Monitor changes in regulations and standards and assess their impact on product compliance.
• Collaborate with cross-functional teams to ensure premarket and commercial products meet quality and safety standards.
• Manage and complete assigned projects within the Regulatory and Quality and teams.
• Experience working with electronics QMS systems to maintain a comprehensive regulatory documentation system to ensure accessibility and traceability of regulatory information. 
• Participate as an Internal Auditor.

Qualifications:

• Educational background: Degree in Engineering (Biomedical preferred), Software, or Applied Sciences or equivalent     experience and knowledge.
• Experience/Certification in Regulatory Affairs covering Health Canada, the US (FDA), UK and the EU. 
• Experience in Regulatory and Quality in a MDSAP/ISO 13485 certified QMS.
• Experience with both hardware and software medical products.
• Internal or external auditing experience in MDSAP and/or ISO 13485
• Strong understanding of Quality Engineering Principles, Quality Improvement processes.
• Familiar with Digital Health technology (IoT, patient worn medical devices)
• Strong collaboration, organizational and project management skills.
• Certification in Quality Management, Medical Device Auditor, Quality Engineer.