Overview
QA & Regulatory Affairs Manager; Dental Dealer Jobs in Markham, Canada at K-Dental Inc.
Position: QA & Regulatory Affairs Manager (Dental Dealer) – 12 Month Contract
K-Dental has been a trusted partner to Canadian dental professionals for over 45 years, offering a comprehensive range of innovative products, equipment, and solutions to help practices thrive. With a strong commitment to service excellence, industry expertise, and long-standing relationships, K-Dental is proud to support the evolving needs of dental offices across the country. We are passionate about driving growth and delivering value both to our clients and within our team.
The QA & Regulatory Affairs Manager is responsible for ensuring compliance with all applicable regulatory requirements and quality standards for the distribution of dental products. This role oversees Quality Assurance systems, regulatory compliance, GMP adherence, and audit readiness, with a strong focus on Health Canada regulations, including MDEL licensing and MDSAP requirements. The position also plays a key role in implementing and maintaining policies and procedures to ensure compliance with regulatory and quality requirements as well as organizational training and development.
Employment Type
- 12-month contract (full-time)
Key Responsibilities Quality Assurance & GMP Compliance
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP, ISO 13485, and MDSAP requirements.
- Ensure compliance with Good Manufacturing Practices (GMP) relevant to storage and distribution activities.
- Support and maintain MDSAP audit readiness and ongoing compliance.
- Conduct internal audits and inspections to ensure continuous improvement and regulatory compliance.
- Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
Regulatory Affairs
- Act as the primary liaison with Health Canada and other regulatory bodies.
- Lead and manage Health Canada inspections and audits, including preparation, execution, and follow-up responses.
- Ensure compliance with Medical Device Establishment License (MDEL) requirements, including application, maintenance, and annual license renewals.
- Maintain regulatory documentation and ensure all distributed products meet Canadian regulatory requirements.
- Support compliance with international regulatory frameworks under MDSAP (Medical Device Single Audit Program).
Audit & Inspection Management
- Prepare the organization for GMP inspections, Health Canada audits, and MDSAP audits.
- Lead audit activities, including hosting auditors, managing documentation, and coordinating responses.
- Ensure timely and effective closure of audit observations and non-conformities.
- Train internal teams on audit readiness and regulatory expectations.
- Develop and implement organizational training on QA policies and procedures to all applicable staff to ensure compliance.
- Collaborate with cross-functional teams (sales, operations, supply chain) to ensure awareness and proactively address any potential issues and or change in procedures required to maintain in compliance.
Documentation & Training
- Develop and maintain Standard Operating Procedures (SOPs) aligned with GMP, MDSAP, and regulatory requirements.
- Ensure document control systems meet compliance standards.
- Deliver training programs on QA systems, GMP, MDEL obligations, and MDSAP requirements.
Qualifications & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Minimum 5–7 years of experience in QA/Regulatory roles within medical devices, dental, or healthcare distribution.
- Proven experience with GMP inspections and compliance programs.
- Direct experience managing Health Canada audits and inspections.
- Hands‑on experience with MDSAP audits and compliance frameworks.
- Strong working knowledge and experience managing MDEL licensing requirements.
- Experience implementing and managing S&OP processes.
- In‑depth knowledge of Health Canada regulations and ISO 13485 standards.
- Experience in dental or medical device distribution is strongly preferred.
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Title: QA & Regulatory Affairs Manager; Dental Dealer
Company: K-Dental Inc.
Location: Markham, Canada
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