Hess Associates
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Vaughan, Ontario (On-Site) | Reports to QA/RA Manager | Full-Time

Our client is a fast-growing health supplements and PPE manufacturer and distributor seeking a hands-on Quality Assurance/Regulatory Affairs Specialist to work on initiatives related to compliance, quality, and regulatory affairs. Reports to the Quality Assurance / Regulatory Affairs Manager.  

What You’ll Do

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

  • Help the Manager develop & maintain SOPs and monitor regulatory compliance.

  • Participate in planning and executing internal/external audits and CAPA programs.

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

  • Monitor regulatory changes and update processes accordingly.

  • Help Build the QMS from the ground up as required.

What You Bring

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

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

  • Background in GMP, NSF standards, and QMS implementation.

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

  • Strong English communication, problem-solving, and team player  skills.

  • Able to work on site.

Why Join Them?

  • Making a contribution with visible results.

  • Career growth to QA/RA Manager.

  • Collaborative and entrepreneurial environment.

  • Competitive salary and benefits.

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