Quality and Regulatory Manager

Smarter Alloys; Cambridge; On-site; CAD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive compensation

Full benefits

Paid vacation

Direct impact on products

On-site Cambridge, ON role

Job summary

Smarter Alloys in Cambridge, ON is seeking a Quality and Regulatory Leader to own the ISO 13485 system, lead audits, and guide regulatory strategy for medical device products from concept through commercialization.

This role partners with engineering and production to maintain a compliant QMS, support regulatory submissions, and drive CAPA and continuous improvement to accelerate market readiness.

Qualifications

• Strong knowledge of ISO 13485 and FDA QSR regulatory expectations.
• Experience leading internal/external audits and regulatory inspections.
• Proven track record managing a Quality Management System hands-on.
• Ability to drive regulatory strategy for new product development.
• Excellent documentation and cross-functional collaboration skills.

Responsibilities

• Lead internal and external audits, including ISO surveillance and regulatory inspections.
• Own and maintain the ISO 13485 Quality Management System for ongoing compliance.
• Support regulatory activities for medical devices, including FDA listings.
• Guide regulatory requirements from concept to commercialization of new products.
• Oversee CAPA, nonconformance, and continuous improvement initiatives.
• Maintain quality docs including SOPs, risk management, and technical files.
• Collaborate with engineering, production, procurement, and business development.

Skills

ISO 13485

FDA QSR

Audits

QMS Leadership

Regulatory Strategy

Education

Bachelor's degree

Job description

Smarter Alloys | Cambridge, ON (On Site) Full Time, 1-Year Fixed-Term

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

• 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

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.