Blackfield Associates
QARA Consultant
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QARA Consultant - Regulatory Consultant
Location: Remote / Hybrid
Contract: Interim / Consultant Assignment
Duration: Initial engagement through year-end, with potential extension
Engagement: Flexible / Fractional (circa 3 days per week)
Overview
We are supporting a growing medical device distribution organisation with an established presence across Europe as it prepares to enter the Canadian market. As part of this expansion, we are seeking an experienced Quality & Regulatory Affairs Consultant to lead the practical implementation of regulatory and quality requirements required to support distribution activities in Canada. This is a hands-on consulting assignment, focused on execution and delivery rather than high-level advisory support. Working closely with the internal Quality team, you will help establish regulatory readiness, support Health Canada requirements, and ensure Canadian-specific processes are effectively embedded into the existing Quality Management System (QMS).
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Key Responsibilities
- Assess existing quality and regulatory processes and identify gaps related to Canadian medical device distribution requirements.
- Support Health Canada licensing and registration activities associated with market entry.
- Define and implement a practical regulatory pathway aligned with product portfolio and manufacturer readiness.
- Update and integrate Canadian regulatory requirements into the existing QMS.
- Draft, review, and maintain SOPs, procedures, and controlled quality documentation.
- Advise on regulatory reporting obligations and compliance requirements relevant to distributors.
- Develop project plans, timelines, and onboarding activities to support successful market entry.
- Provide ongoing regulatory and quality guidance to internal stakeholders throughout the project lifecycle.
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Required
- Proven experience supporting Health Canada regulatory pathways for medical devices.
- Strong understanding of medical device Quality Management Systems, including SOP development, document control, and process implementation.
- Previous experience working within a medical device distributor environment or supporting distributor market-entry activities.
- Ability to translate regulatory requirements into practical business processes and QMS improvements.
- Comfortable operating in a hands-on consulting capacity and working closely with cross-functional teams.
- Strong project management and stakeholder engagement skills.
- Experience navigating ambiguity and building structured plans in evolving project environments.
This is an independent consultant assignment. Candidates must be located in UK or Ireland, with no requirement for sponsorship.
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