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Regulatory Affairs Specialist

4 weeks ago

Ontario, Canada Szio+ Inc Full time €70,000

Regulatory Affairs Specialist – Natural Health Products & Medical Devices (Canada)**Location:** Ontario, Canada (Remote or Hybrid) About the Role: Szio+ Inc is looking for a Regulatory Affairs Specialist to help with compliance and regulatory review in Canada and US. You’ll play a key role in supporting product licensing, managing submissions, and reviewing content to ensure compliance across packaging, website, retailer listings, and marketplace platforms. What You’ll Do: Prepare and submit regulatory applications and license renewals for Natural Health Products (NHPs) and Medical Devices with Health Canada and the FDA. Review and approve website, retailer, and marketplace listings, as well as advertising and promotional materials, to ensure compliant language and claims. Monitor and maintain compliance for product packaging, ingredient listings, and related documentation. Track and organize regulatory submissions, renewals, and communications with Health Canada. Stay current with updates to Natural Health Product Regulations and Medical Device Regulations, and communicate relevant changes to internal teams. Partner with marketing, product development, and quality teams to support compliant product launches and campaigns. Provide strategic input on labeling, claims, and marketing copy to ensure it aligns with regulatory expectations. What You Bring: Bachelor’s degree in a relevant field (Life Sciences, Regulatory Affairs, Pharmacy, or related discipline). Minimum of 2–5 years of experience in regulatory affairs for Natural Health Products or Medical Devices in Canada and the US. Solid understanding of Health Canada’s Natural Health Products Regulations (NHPR) and Medical Devices Regulations in both Canada and the US. Hands-on experience preparing and submitting NPNs and/or Medical Device License applications (Class I–III). Strong attention to detail and the ability to interpret and apply regulatory requirements to marketing content. Excellent communication and collaboration skills. Nice to Have: Regulatory Affairs Certification (RAC) or equivalent designation. Experience with e-commerce or retail marketplaces (e.g., Amazon, Walmart, Shopify). Familiarity with international regulatory frameworks (e.g., FDA, EMA). Company Szio+ is a Canadian based, healthcare company founded to lead the prevention and wellness industry by building brands focused on chronic disease management. Utiva is focused on Women's Health including UTI prevention, OAB relief, Vaginal Infections and Menopause. Ferosom Forte is a brand focused on improving iron deficiency anemia. Job Type: Full-time Pay: From $70,000.00 per year Schedule: Monday to Friday Experience: Healthcare regulatory: 2 years (Required) Work Location: Hybrid