Overview

JWe are looking for a Quality & Regulatory Affairs Associate to support the development and maintenance of our Quality Management System and regulatory activities. This role will help ensure our products, processes, and documentation meet applicable quality and regulatory requirements. The ideal candidate has a strong technical background, experience with quality systems and audits, and the ability to manage regulatory documentation, risk assessment, and compliance activities.

Duties

- Support the development, implementation, and maintenance of the company’s Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 requirements.
- Establish, maintain, and complete quality and regulatory templates, forms, procedures, and records.
- Prepare, review, and submit quality and regulatory documentation, including hardware and software technical documentation required for regulatory submissions.
- Support regulatory submissions, registrations, renewals, and filings as required.
- Conduct risk management activities, including identifying and assessing risks, developing mitigation strategies, monitoring risks, and supporting the resolution of identified issues.
- Support the identification, investigation, documentation, and resolution of non-conformances, deviations, complaints, and CAPAs.
- Prepare for and support third-party audits, including ISO and other applicable quality or regulatory audits.
- Maintain document control and ensure quality and regulatory documentation is accurate, current, complete, and properly maintained.




- Monitor applicable regulatory requirements, standards, and guidelines and assist in assessing their impact on company products and processes.
- Support supplier quality and compliance activities, including reviewing supplier documentation.
- Assist with quality and regulatory training and promote compliance with applicable SOPs and procedures.
- Monitor quality and regulatory metrics and support continuous improvement initiatives.
- Work collaboratively with Engineering, Manufacturing, and other cross-functional teams to identify and resolve quality and regulatory issues.

Qualifications

- Degree or diploma in Engineering, Science, Quality, Regulatory Affairs, or a related field, or equivalent relevant work experience.
- Experience with quality management systems, preferably with knowledge of ISO 9001 and ISO 13485.
- Experience preparing hardware and software technical documentation for regulatory submissions.
- Experience with risk management, including risk assessment, mitigation, and resolution.
- Experience supporting or participating in third-party audits, such as ISO audits or similar quality/regulatory audits.
- Strong analytical, problem-solving, organizational, and documentation skills.




- Excellent attention to detail and ability to manage multiple priorities.
- Ability to work effectively with engineering, manufacturing, and cross-functional teams.

We offer

- Full-time employment
- Competitive base salary
- Comprehensive Benefits package
- RRSP match
- A dynamic and engaging work environment
- Career development opportunities

Accepting applicants from Canada without need for company sponsorship to work.

Disclosure

The final salary awarded for this role may vary from the above range based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, performance, and business or organizational needs. The wage range provided in this job posting may be subject to change for business purposes.

Equal opportunity

At n!Biomachines, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. n! biomachines is proud to be an equal prospect workplace and we are committed to creating an inclusive environment for all employees.

If you have any accommodation requirements, please let us know. We will do our best to meet your needs in accordance with applicable local legislation.

Pay: $50,000.00-$65,000.00 per year

Benefits

- Disability insurance
- Employee assistance program
- Extended health care
- On-site parking
- RRSP match
- Vision care

Work Location: In person

📌 Quality and Regulatory Affairs Associate (Burlington)
🏢 n! biomachines
📍 Burlington