**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.
Pay: $75,000.00-$80,000.00 per year
Benefits:
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Tuition reimbursement
- Vision care
Work Location: In person
