At a Glance
- Tasks: Lead the implementation of regulatory and quality requirements for medical device distribution in Canada.
- Company: Growing medical device distribution organisation expanding into the Canadian market.
- Benefits: Flexible working hours, remote/hybrid options, and potential for contract extension.
- Other info: Independent consultant role; must be based in the UK or Ireland.
- Why this job: Make a real impact in a hands-on role while shaping regulatory processes for market entry.
- Qualifications: Experience with Health Canada regulations and strong project management skills required.
The predicted salary is between 50000 - 65000 £ per year.
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).
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 UK or Ireland, with no requirement for sponsorship.
QARA Consultant in Exeter 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.
StudySmarter Expert Advice🤫
We think this is how you could land QARA Consultant in Exeter
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
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Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Blackfield Associates.
We think you need these skills to ace QARA Consultant in Exeter
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Blackfield Associates.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Blackfield Associates. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Blackfield Associates.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Blackfield Associates achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
