Product Compliance & Regulatory Affairs Specialist

Product Compliance & Regulatory Affairs Specialist

**Must be willing to work on-site in Markham office 5 days/week**

We are seeking a Product Compliance & Regulatory Affairs Specialist to ensure our products meet all necessary regulatory and compliance requirements across Canada and the USA.

Key Responsibilities:

• Regulatory Compliance & Documentation Ensure all products comply with applicable regulations (e.g., FDA, Health Canada, CE, ISO, RoHS, REACH). Prepare and maintain regulatory filings, product registrations, and technical documentation. Manage certifications and liaise with regulatory agencies as needed.
• Labeling & Safety Compliance Review product labels, packaging, and marketing materials for regulatory accuracy. Ensure proper documentation and distribution of Safety Data Sheets (SDS/MSDS).
• Cross-functional Collaboration Work closely with Procurement, Legal, and Marketing teams to integrate compliance requirements into product development. Provide regulatory guidance for new product launches and market expansions.
• Audits & Risk Management Support internal and external audits, inspections, and regulatory submissions. Develop and implement corrective action plans to address compliance risks.
• Monitoring & Reporting Stay updated on changes in regulations and industry standards. Assess and communicate regulatory risks and requirements to leadership.

Qualifications & Experience:

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
• 3+ years of experience in regulatory affairs, compliance, or a related field.
• Strong knowledge of regulatory frameworks (e.g., FDA, Health Canada, CE, ISO 13485, RoHS, REACH).
• Experience with technical documentation, audits, and risk management.
• Strong attention to detail, problem-solving skills, and ability to work cross-functionally.
• Experience in the dental industry, an asset.
• Familiarity with regulatory submission software and compliance databases.
• Knowledge of international regulatory requirements.

Why join us? (Brace yourself…)

• We offer competitive compensation
• Extended Health and Dental Benefits Plan (100% Employer-paid Premiums on eligible benefits)
• Continuous Learning Assistance Program reimbursing up to $1,500 per calendar year
• Group RRSP (Non-match)
• 15 Vacation Days to start and scale to 20 Vacation Days.
• Paid Religious Holidays
• Paid Volunteer Days
• Flexibility to help you balance work and life
• Corporate GoodLife Fitness Membership Discount
• Supportive leadership team and Culture Committee that works to maintain a positive culture
• Competitive yet collaborative work environment
• Fully stocked snacks, team BBQs and other company paid meals (we love to eat!)