Medical Device Consultant jobs

Location: Hybrid – GTA, Ontario, Canada

Job Type: Independent Contractor / Consulting Agreement

Compensation: Negotiable based on experience and project scope

About Opulence Global

Opulence Global is an international direct-selling company offering health, wellness, and personal care products across multiple markets.

We are seeking an experienced Regulatory Affairs Consultant to provide independent, project-based regulatory expertise, support product compliance, and facilitate product registrations in Canada and international markets.

The ideal candidate is a resourceful, detail-oriented regulatory professional who understands the complexities of natural health products, dietary supplements, and international regulatory requirements and can provide practical, commercially viable solutions.

Key Responsibilities

1. Regulatory Compliance & Product Registration

• Manage and support Natural Product Number (NPN) applications, amendments, and regulatory submissions to Health Canada.
• Assess product formulations, ingredients, dosages, and health claims for regulatory compliance.
• Review product labels, packaging, marketing materials, and product information to ensure compliance with applicable regulations.
• Identify regulatory risks and recommend practical solutions to achieve compliance.
• Monitor regulatory changes and advise on their potential impact on existing and future products.

2. International Product Registration & Market Expansion

• Research and assess regulatory requirements for introducing products into new international markets.
• Coordinate product registration and notification processes with international regulatory authorities, local representatives, and distributors.
• Identify country-specific requirements for ingredients, formulations, product classification, labeling, and health claims.
• Prepare, review, and organize technical documentation required for international registrations.
• Evaluate regulatory feasibility, timelines, and potential barriers before entering new markets.

3. Technical Documentation & Regulatory Support

• Review and prepare regulatory documentation, including:
• Certificates of Analysis (COA)
• Certificates of Free Sale (CFS)
• Product specifications and ingredient documentation
• Manufacturing and GMP documentation
• Safety, stability, and efficacy supporting documentation
• Ingredient monographs and technical dossiers
• Liaise with manufacturers, laboratories, suppliers, and regulatory authorities to obtain required information.
• Identify documentation gaps and recommend corrective actions.

4. Product Development & Regulatory Strategy

• Provide regulatory guidance during new product development, reformulation, and product launches.
• Assess proposed ingredients and formulations before manufacturing to minimize regulatory delays.
• Recommend compliant alternatives when ingredients, dosages, or claims present regulatory challenges.
• Develop practical regulatory strategies that balance compliance, cost, and speed to market.

Qualifications & Experience

Required:

• Minimum 5 years of professional experience in regulatory affairs, preferably involving natural health products, dietary supplements, or nutraceuticals.
• Demonstrated experience with Health Canada's Natural Health Products Regulations and NPN licensing process.
• Experience preparing and reviewing regulatory submissions and technical documentation.
• Knowledge of ingredient safety, product classification, labelling, and health claim requirements.
• Experience supporting international product registrations or market-entry compliance.
• Strong written communication, research, analytical, and problem-solving skills.
• Ability to work independently, manage multiple projects, and provide clear, actionable recommendations.

Strong Assets:

• Experience with regulatory requirements in Asia-Pacific, the Middle East, the European Union, and the United States.
• Familiarity with FDA dietary supplement regulations and international food supplement frameworks.
• Experience working with contract manufacturers, laboratories, and international distributors.
• Background in pharmaceutical sciences, chemistry, food science, toxicology, or a related discipline.
• Experience developing regulatory strategies for products distributed through direct-selling or international distribution networks.

Contract Arrangement

This is an independent contractor position, not a permanent full-time employment opportunity.

The consultant will work on an as-needed, project-based basis, with the potential for an ongoing consulting relationship.

The scope of work, deliverables, timelines, and compensation will be agreed upon for each engagement.

How to Apply

Please submit your resume or professional profile along with a brief summary addressing:

• Your experience with Health Canada NPN applications and natural health product compliance.
• The international markets where you have successfully supported product registrations.
• Examples of regulatory challenges you have resolved.
• Your preferred consulting fee structure (hourly rate, project-based fee, or retainer).
• Your availability to take on new projects.

We are particularly interested in consultants who can offer practical solutions, independent regulatory judgment, and hands-on support rather than advisory services alone.

Benefits:

• Company events
• Flexible schedule
• On-site parking
• Store discount
• Work from home

Application question(s):

• Have you personally prepared and submitted Natural Product Number (NPN) applications to Health Canada?
• Which international markets have you directly supported with product registration or regulatory compliance? Please specify your role.
• Please provide your hourly rate or preferred fee structure.

Experience:

• hands-on regulatory affairs: 5 years (required)

Work Location: In person