Regulatory and Quality Leader

Smarter Alloys is seeking a Quality and Regulatory Manager in Cambridge, ON to lead the charge in regulatory compliance for medical devices. Drive product success by ensuring quality systems are robust and effective.

This permanent full-time role will have you owning the ISO 13485 system while guiding regulatory strategies for both new and existing products. Your ability to facilitate audits and manage regulatory inspections will be critical as Smarter Alloys expands its offerings. Work closely with teams across engineering, production, and supplier partnerships to uphold quality standards.

Key Responsibilities:

• Conduct internal and external audits for ISO and regulatory bodies

• Maintain and enhance the ISO 13485 Quality Management System

• Facilitate regulatory activities for FDA and Health Canada

• Lead CAPA and nonconformance management processes

• Train and support teams on regulatory compliance

Requirements:

• Bachelor's degree in Engineering, Science, or similar

• 4+ years in quality/regulatory roles, preferably in medical devices

• Solid understanding of ISO 13485 and FDA guidelines

• Proven audit leadership and inspection management skills

• Excellent documentation and communication abilities

Be the cornerstone of compliance and quality at Smarter Alloys and shape the future of product delivery.
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