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.
What You Will Do
- 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
Who You Are
- 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
Strongest candidates will also have:
- 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
What We Offer
- Competitive compensation package with full benefits and paid vacation
- The chance to own and shape the quality function at a company with real momentum
- Direct impact on products reaching market. Your work clears the path.
- A fast moving, collaborative team that values results and initiative
- On site role based out of our Cambridge, ON facility
