At a Glance
- Tasks: Lead regulatory and quality implementation for a medical device company entering the Canadian market.
- Company: Growing medical device distribution organisation with a strong European presence.
- Benefits: Flexible working hours, remote/hybrid options, and potential for contract extension.
- Other info: Independent consultant role with opportunities for project management and stakeholder engagement.
- Why this job: Make a real impact in a hands-on role while shaping regulatory processes.
- Qualifications: Experience with Health Canada regulations and medical device Quality Management Systems.
The predicted salary is between 50000 - 65000 £ per year.
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).
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.
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 the UK or Ireland, with no requirement for sponsorship.
QARA Consultant in Plymouth employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, particularly for the role of Plant Quality Manager in Folkestone. Our commitment to fostering a collaborative work culture is complemented by robust employee growth opportunities and a focus on continuous improvement, ensuring that our team members thrive both personally and professionally. With a strong emphasis on quality and regulatory compliance, we offer a dynamic environment where your expertise will be valued and your contributions will directly impact our success.
