Senior Manager, Global Regulatory Affairs
Waterloo, ONNDI (Northern Digital Inc.)
10+ YOE5+ MgmtCandidates need a science or engineering background, 10 or more years in medical device regulatory affairs including 5 years leading teams, and strong FDA and EU MDR experience. Proven leadership, strategic planning and stakeholder management skills are required.
Regulatory affairs, Medical devices, Regulatory compliance, Leadership, Strategic planning, Stakeholder management
Vice President, Global Quality Assurance & Regulatory Affairs
Waterloo, ONNDI (Northern Digital Inc.)
15+ YOE7+ MgmtCandidates need a bachelor's degree in engineering, life sciences or a related field, 15+ years of medical device QA and/or regulatory experience, and 7+ years of senior leadership. They need deep knowledge of ISO 13485, ISO 14971, FDA QMSR and international regulatory frameworks.
electronic quality systems