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.
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.
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.
High-impact role with visible results.
Career growth to QA/RA Director.
Collaborative and entrepreneurial environment.
Competitive salary and benefits.