About the Role

Quality Smart Solutions Inc. is a science and compliance consulting firm globally serving consumer health product companies in Natural Health Products, Dietary Supplements, Over-The-Counter DIN products, Foods and Cosmetics regulatory and quality areas.

Our fast, cost effective, solutions-oriented approach has ensured client satisfaction and has established Quality Smart Solutions as the preferred partner in science and compliance having served over 600 global clients, licensing over 5000 products and sites and completed over 15,000 projects.

We are seeking an energetic, detail-oriented Regulatory Affairs & Quality Consultant/Specialist to execute complex regulatory projects, manage client relationships, and deliver strategic compliance solutions.

In this role, you will work directly with our clients across the NHP, food, pharmaceutical, and medical device sectors. You will own end-to-end Health Canada submissions, draft technical rationales and SOPs, respond to agency deficiency notices, and manage day-to-day project workflows within budgeted hours.

Key Responsibilities

- Regulatory & Quality Project Execution: Execute standard regulatory projects independently. Author scientifically sound regulatory submissions, label reviews, strategies, rationales, technical arguments, and responses to Health Canada Information Request Notices (IRNs) or Clarification Requests. Draft and implement client SOPs and Quality Systems.
- Knowledge Transfer & Education:



Provide training and education on regulatory matters to internal and external stakeholders and provide regulatory input to affiliate strategic initiatives.
- Account & Client Management: Serve as the day-to-day face of the firm for assigned clients. Lead kickoff meetings, provide weekly status updates, and translate complex regulatory requirements into actionable business solutions.
- Project Management & Budget Discipline: Manage an active queue of client deliverables using Project Management tools. Track project status daily and execute tasks strictly within allocated/budgeted hourly limits.

Qualifications

- Education: Bachelor’s degree in Science, Chemistry, Biochemistry, Food Science, Pharmacy, or a related health field. A Post-Graduate Certificate in Regulatory Affairs or Quality Assurance is a strong asset.
- Experience: Minimum 3+ years of regulatory affairs and/or quality assurance experience in the pharmaceutical, nutraceutical, medical device, or food industries.
- Submissions Track Record: Proven experience preparing, submitting, and managing product applications to Health Canada (e.g., NPNs, DINs, MDLs, or Food notifications).
- Robust Assets:
- Direct regulatory experience in the Canadian Food Sector (Supplemented Foods, Novel Foods, Labelling).




- Hands-on familiarity with US FDA regulatory submissions and compliance rules.
- Technical Writing: Exceptional ability to translate complex scientific data into compliant regulatory arguments and deficiency responses.
- Client & Project Skills: Strong client-facing communication skills, comfortable leading meetings, and experienced with time-tracking/project management tools.
- Problem Solving & Agility: Innovative problem solver and agile decision-maker who thrives under changing regulatory landscapes.
- Communication & Influence: Excellent oral/written communication skills with strong presentation, negotiation, and stakeholder management abilities.

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Equal Prospect Employment

Quality Smart Solutions is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We encourage applicants from all backgrounds, regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or any other characteristic protected by law. We believe in providing equal opportunities for employment, advancement, and professional development to all individuals.

If you require accommodations during the application process, please contact us at [email protected], and we will work to ensure that your needs are met.

Pay: $42,500.00-$85,000.00 per year

Benefits:

- Work from home

Work Location: Remote

📌 Regulatory Affairs & Quality Consultant (Canada)
🏢 Quality Smart Solutions
📍 Canada