Quality and Regulatory Manager

Smarter Alloys•Cambridge, ON

2d•Onsite

About The Position

This is a role where quality and regulatory work directly enables products to reach market. You will own our ISO 13485 system, lead audits, and guide regulatory strategy for new and existing medical device products, but the real impact is in clearing the path from development to commercialization. We need someone who can balance maintaining a certified QMS with actively supporting new product introductions, navigating regulatory submissions, and working shoulder to shoulder with engineering and production as we scale. If you want a role where compliance isn't a back office function but a core part of how products get to market, this is it. Smarter Alloys develops and manufactures advanced shape memory alloy materials and devices for medical, dental, automotive, consumer, and energy applications. We are certified to ISO 13485 MDSAP and registered with the FDA and Health Canada. Our product portfolio is expanding, our customer base is growing, and we need a quality and regulatory leader who can scale with us.

Requirements

Bachelor's degree in Engineering, Science, or a related technical discipline
4+ years of experience in quality and regulatory roles within the medical device industry
Strong working knowledge of ISO 13485 and FDA Quality System Regulation
Demonstrated experience leading audits and managing regulatory inspections
Proven ability to manage and improve a QMS in a hands on environment
Strong documentation, organizational, and communication skills
Able to work independently and exercise sound judgment in a regulated setting

Nice To Haves

Experience supporting dental or Class I/II medical devices
Familiarity with ISO 14971 (risk management)
Experience in a startup or growing organization
Exposure to advanced materials or precision manufacturing environments
Experience supporting regulatory submissions or international registrations

Responsibilities

Lead internal and external audits, including ISO surveillance audits, customer audits, and regulatory inspections
Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and continuous improvement
Support regulatory activities for medical device products, including FDA establishment registration and listing
Guide regulatory requirements for new product development from concept through commercialization
Oversee CAPA, nonconformance management, and continuous improvement initiatives
Maintain and improve quality documentation including SOPs, work instructions, risk management files, and technical files
Support supplier qualification, monitoring, and quality agreements
Train and support internal teams on quality system requirements and regulatory expectations
Collaborate cross functionally with engineering, production, procurement, and business development
Serve as the primary point of contact for quality and regulatory matters, internally and externally