Hess Associates
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Vaughan, Ontario (On-Site) | Reports to President | Full-Time

Our client is a fast-growing health supplements and PPE manufacturer and distributor seeking a hands-on Quality Assurance/Regulatory Affairs Manager to lead compliance, quality, and regulatory initiatives. Reports to the President. This role offers direct impact, cross-functional influence, and a clear path to QA/RA Director as they expand.

What You’ll Do

  • Lead regulatory submissions (Health Canada, NSF, FDA) and product/site licensing.

  • Develop & maintain SOPs and oversee regulatory compliance monitoring.

  • Plan and execute internal/external audits and manage CAPA programs.

  • Partner with R&D, Manufacturing, and Supply Chain to embed compliance in daily operations.

  • Monitor regulatory changes and update processes accordingly.

  • Build their QMS from the ground up.

What You Bring

  • 5+ years in combined QA/RA roles in natural health products, nutraceuticals, food manufacturing, PPE, medical devices, or pharmaceuticals.

  • Proven success in regulatory submissions to Health Canada, NSF, or FDA.

  • Strong knowledge of GMP, NSF standards, and QMS implementation.

  • Bonus: Familiarity with ISO 13485 and/or Health Canada Medical Device Regulations.

  • Leadership style: Proactive, organized, and able to take ownership.

  • Excellent communication, problem-solving, and stakeholder management skills.

Why Join Them?

  • High-impact role with visible results.

  • Career growth to QA/RA Director.

  • Collaborative and entrepreneurial environment.

  • Competitive salary and benefits.

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