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Quality Regulatory Affairs of Medical Devices jobs

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    • Experience: Minimum 3+ years of regulatory affairs and/or quality assurance experience in the pharmaceutical, nutraceutical, medical device, or food…
    • View all Quality Smart Solutions jobs - Canada jobs - Regulatory Affairs Specialist jobs in Canada
    • Salary Search: Regulatory Affairs & Quality Consultant salaries in Canada
    • Escalate significant regulatory risks, conflicting priorities or implementation issues to senior regulatory leadership with recommended next steps.
    • As a key member of the leadership team, the VP will be responsible for ensuring the highest standards of product quality, safety, regulatory compliance, and…
    • Proficiency with MS Office 365 and medical terminology.
    • Strong, up-to-date knowledge of Credentialing standards, Canadian provincial medical/ professional…
    • 7 to 10 years of experience in the pharmaceutical or biotechnology industry; at least 5 of those years in Regulatory Affairs.
    • Proficient in MS Office suite.
    • Your responsibilities encompass a wide range of tasks, all aimed at ensuring the smooth flow of regulatory processes and the successful approval of drug…
    • You have 3-5 years of QA/RA experience in medical devices, diagnostics, or another regulated industry where records are part of the work rather than paperwork…
    • This role may also involve supporting quality-related activities with external suppliers, including the collection and monitoring of supplier quality…
    • A track record of applying innovative thinking to complex regulatory challenges and driving continuous improvement.
    • Keeps abreast of regulatory procedures and changes.
    • Experience in regulatory affairs through internship role/s, preferably in the medical device industry.
    • Assess the potential impact of proposed changes on product quality, sterility assurance, validated state, regulatory commitments, qualification status, training…
    • 3+ years of experience in product quality, product testing, validation, regulatory compliance, or a related engineering role.
    • 6 personal days per calendar year.
    • Minimum of 5 years of experience in the pharmaceutical industry in Quality.
    • Ensure the implementation, maintenance, and continuous improvement of a quality…
    • Soutenir le programme d’audits externes des fournisseurs ainsi que le programme d’audits internes, selon les besoins et les priorités établies.
    • 3+ years of QA experience in the pharmaceutical or medical device industry.
    • Employees may be eligible to participate, with API matching of contributions up to 1…
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Job Post Details

Regulatory Affairs & Quality Consultant
Quality Smart Solutions
Canada
•
Remote
$42,500–$85,000 a year
Full-time
Apply now

Job details

$42,500–$85,000 a year
Work from home
Full-time
Remote in Canada

Full job description

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).
  • Strong 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.

*

Equal Opportunity 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 careers@qualitysmartsolutions.com, 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

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