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Regulatory Affairs and Quality Assurance
Employer undisclosedRole managed by a recruiter
Regulatory & Quality Assurance professional for medical devices, pharma, NHP
13d ago
C$60,000 - C$130,000
Expert & Leadership (13+ years)
Full Time
Vancouver, British Columbia, Canada
Hybrid
Role
What you would be doing
compliance management
audit support
regulatory submissions
team collaboration
quality systems
risk management
- Maintain compliance with ISO 13485, ISO 14971, CFR 21 Part 11/820, MDSAP, GMP, GLP, and other relevant standards.
- Support regulatory inspections and third-party audits.
- Stay current with evolving global regulations and provide guidance on compliance strategies.
- Support or lead regulatory submissions (FDA, Health Canada, EU MDR/IVDR, and other global health authorities).
- Collaborate with cross-functional teams (R&D, Manufacturing, Clinical, Operations) to ensure regulatory and quality requirements are integrated throughout the product lifecycle.
- Oversee or contribute to quality systems, including SOPs, CAPA, risk management, audits, and post-market surveillance.
What you bring
quality management
medical devices
regulatory affairs
rac
leadership
bachelor's
- Strong understanding of Quality Management Systems and regulatory frameworks.
- North American industry experience in Medical Devices, Pharmaceuticals, or Natural Health Products (required).
- Excellent communication, documentation, and problem-solving skills.
- QARA Specialist – 5+ years of experience
- ROW (Rest of World) regulatory experience preferred, including EU, APAC, LATAM, or global submissions.
- QARA Manager – 5+ years of experience, with leadership responsibility
- Bachelor’s degree or higher in Life Sciences, Engineering, or a related discipline.
- RAC (Regulatory Affairs Certification) preferred; additional certifications (e.g., ASQ CQA, ISO Lead Auditor) are assets.
- Ability to work independently and collaboratively in fast-paced environments.
- QARA Lead – 3+ years of experience
- QARA Associate – 0–2 years of experience
- Career growth across multiple levels of QARA.
- Roles available in on-site, hybrid, and fully remote settings.
- Opportunities across startups, scale-ups, and commercial-stage companies.
- The chance to make a meaningful impact in patient health and product safety.
- Competitive compensation ($60K–$130K, dependent on experience and role).
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