Remote SaMD Regulatory & Quality Strategist

Rellia Health; Canada; Remote; CAD 83,000 - 165,000; Part time

Job summary

Rellia Health in Canada offers regulatory and quality consulting for early‑stage SaMD and medical device startups. This is virtual, project‑based, independent contractor work with no minimum hourly commitment and total flexibility in hours and rate.

You will guide clients on regulatory compliance and quality management systems, develop QMS, conduct mock audits, analyze requirements, and advise strategies for compliance and documentation.

Qualifications

• Translate regulatory standards into practical, maintainable systems (QMS, documentation)
• Guide mock audits and regulatory reviews for SaMD/medical device startups
• Know regulatory requirements for Health Canada licensing and EU/US pathways
• Understand cybersecurity and privacy regulations in health tech
• Present directly to customers and regulators with clarity and credibility
• No prior consulting experience required; capable self-starter for startups

Responsibilities

• Develop quality management systems for SaMD clients
• Conduct mock audits and analyze regulatory requirements
• Advise on FDA SaMD guidance, 510(k), De Novo, or PMA submissions
• Apply ISO 13485 / MDSAP and IEC 62304 practices for lean startup teams
• Guide cybersecurity, privacy, and product documentation to meet industry standards
• Present directly to customers and regulators with practical, maintainable compliance systems

Skills

Regulatory compliance

Quality Management Systems

FDA SaMD guidance

510(k) submissions

IEC 62304 practices

ISO 13485 familiarity

Regulatory strategy

Presenting to regulators

Lean startup adaptation

Job description

Rellia Health in Canada offers regulatory and quality consulting for early‑stage SaMD and medical device startups. This is virtual, project‑based, independent contractor work with no minimum hourly commitment and total flexibility in hours and rate.

You will guide clients on regulatory compliance and quality management systems, develop QMS, conduct mock audits, analyze requirements, and advise strategies for compliance and documentation.