Regulatory Specialist

The Role

At SellerX we are growing our Operations department and now we are looking for a Regulatory Specialist to join our team.

Key responsibilities include:

• Supports Global Head of Regulatory & Product Compliance in assigned product categories such as Formulated Products (Supplements, Packaged Food, Cosmetics, Personal Care, OTC Drugs), Medical devices, Plants, Soil and Plant Products, and any other category dependant on the needs of the business.
  • Review products including existing as well as new products and assist with classifications within assigned product categories
  • Identify applicable product requirements, packaging and labeling requirements, documentation requirements, potential safety issues, manufacturing process requirements (cGMP, ISO 13485, etc.), which must be met.
  • Verify product safety documentation provided by manufacturers and facilitate testing according to internal policies.
  • Guide Commercial team(s) in the use of specific formulations / ingredients to reduce risk/lead times and assist with international market expansion
  • Review packaging of new products to determine compliance with applicable regulations. Identify & Verify claims, using legal references, predicate products, literature review.
  • Create artwork guides and check artwork for compliance
  • Guide artwork creators on the mandatory content and mandatory style guides. Review marketing claims to ensure products are marketed within regulations

• Product Notification / Registration - Complete registrations / notifications where applicable (i.e. FDA, USDA, EPA, etc.)
• Batch control - Verify that each batch is accompanied with the relevant proof of compliance, verify the content and methods used are aligned with the regulations as well as the company policies
• Coordinate with external 3rd parties (Laboratories, consultants, regulators)
  • Selection and Onboarding
  • Scope & Process alignment on all assigned requests.
  • Initiation of services and projects
  • Document retention (test reports, SDS, declarations, registrations, and any other documents deemed suitable at the time)
  • Payments / Invoicing
• Product Category assignment is dependent upon past experience and may change upon discretion of management.

Your Background

To join our team, you bring along

• Bachelors degree, preferably in science, engineering, or similar
• 2+ years industry experience in medical devices, food, nutritional supplements, and formulated products or associated industries is preferred primarily in regulatory affairs, regulatory compliance, quality, nutrition or product development.
• Product safety and compliance international experience (not limited to but focus is mainly US, Canada, UK, and EU)
• Strong analytical and problem-solving skills with great attention to detail.
• Highly organized with a strong operational focus
• Team player with strong interpersonal and communication skills
• Experience using Microsoft Office Suite (Outlook, Word, Excel, Powerpoint)
• Ability to utilize / learn software or technical applications and systems at an intermediate level.
• Sound business judgment with the ability to simplify complex issues and find practical solutions

Sounds exciting but you're not sure if you tick all the boxes? We are always happy to read your application and hear your story. Everyone's talent is unique!