Quality and Regulatory Manager
Smarter Alloys | Cambridge, ON (On Site) Full time, permanent
The Role
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.
About Smarter Alloys
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.
What You Will Do
Who You Are
Strongest candidates will also have:
What We Offer
Smarter Alloys is committed to building a diverse and inclusive team. We welcome applications from women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI+, veterans, and people with disabilities.
Quality and Regulatory Manager • Cambridge, ON, Canada
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