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Quality and Regulatory Manager
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Job Description – Quality and Regulatory Manager
You are an experienced quality and regulatory professional looking to take full ownership of a certified Quality Management System, support new product introductions, and serve as the internal authority on compliance and regulatory execution. You want a role where your work directly enables products to reach market and scale responsibly. Smarter Alloys is that company, and this is that role.
Who We Are
Smarter Alloys is at the forefront of the smart materials revolution. Our programmable shape memory alloy technology is enabling innovation across medical and dental devices, automotive systems, consumer electronics, and beyond. We are a dynamic, fast-moving company with certified systems in place and an expanding product portfolio.
The Role
We are seeking a Quality and Regulatory Manager to own, maintain, and continuously improve our ISO 13485 Quality Management System while supporting regulatory activities for existing and new medical device products. You will be the internal subject-matter expert for quality and regulatory compliance, responsible for audits, registrations, documentation, and cross-functional support throughout product development and production.
This is a hands‑on role suited for someone who thrives in a startup or scale‑up environment, is comfortable balancing strategy with execution, and can confidently interface with auditors, regulators, and customers.
Key Responsibilities
- Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and effectiveness.
- Lead internal and external audits, including ISO audits, customer audits, and regulatory inspections.
- Support regulatory activities for medical device products, including FDA establishment registration and listing.
- Guide regulatory requirements for new product development from concept through commercialization.
- Maintain and improve quality documentation, including SOPs, work instructions, risk management files, and technical documentation.
- Oversee corrective and preventive actions (CAPA), nonconformance management, and continuous improvement initiatives.
- Support supplier qualification, monitoring, and quality agreements as required.
- Collaborate cross‑functionally with engineering, production, procurement, and business development teams.
- Train and support internal teams on quality system requirements and regulatory expectations.
- Serve as the primary point of contact for quality and regulatory matters internally and externally.
Qualifications
- 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.
- Ability to work independently and exercise sound judgment in a regulated setting.
Assets (Nice-to-Haves)
- Experience supporting dental or Class I and II medical devices.
- Familiarity with risk management standards (ISO 14971).
- Experience in a startup or growing organization.
- Exposure to advanced materials or precision manufacturing environments.
- Experience supporting regulatory submissions or international registrations.
Working @ Smarter Alloys
This is a full‑time, permanent hybrid position, based out of our Cambridge, ON facility. The role combines on‑site presence for audits, production support, and cross‑functional collaboration with flexibility for remote work where appropriate. We offer a competitive compensation package, full benefits, paid vacation, and the opportunity to play a critical role in enabling the growth of a cutting‑edge technology company.
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