Regulatory Specialist III
Listed on 2026-02-01
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Healthcare
Healthcare Compliance, Healthcare Management
Regulatory Specialist III
Location: Fresno, CA or Walton, KY (In-Office)
Compensation: $32.00 – $42.00 per hour (based on experience)
Schedule: Monday–Friday, 8:00 AM – 5:00 PM (with some flexibility)
Travel: None
Our client is a premier international food and beverage manufacturer, crafting high-quality, innovative products—from premium ingredients to ready-to-serve solutions—for major restaurant chains, healthcare providers, and food service operators worldwide. With a rich heritage and a forward-thinking approach, they deliver thousands of diverse items that meet evolving consumer and regulatory demands.
Here, your expertise directly shapes compliant, market-leading products while collaborating with dynamic cross-functional teams. If you're a strategic regulatory professional passionate about food science, claims substantiation, and navigating complex FDA/FTC landscapes, this is your chance to make a meaningful impact in a collaborative, growth-oriented environment where your contributions drive business success and innovation.
Key Responsibilities- Lead regulatory support for healthcare/nutrition product lines, including managing technical requests, commercialization processes, and customer-specific documentation to exceed expectations on accuracy and speed.
- Develop and substantiate compliant product claims (health, nutrition, functional) with robust scientific evidence; guide Marketing, Sales, and R&D on FDA, FTC, and global guardrails.
- Oversee label development, formula management, unit/case coding, and change processes to ensure full compliance across regions.
- Handle export documentation (Certificates of Free Sale, Health/Quality Certs, Declarations) and serve as the go‑to expert for healthcare regulatory needs.
- Monitor emerging regulations, assess risks, and proactively recommend updates to company policies and procedures.
- Review raw material documentation for clarity and compliance; act as technical liaison with external partners and organizations.
- Manage large‑scale documentation projects and support customer portals/software with precision and efficiency.
- Provide backup leadership to the Regulatory Manager and contribute to team success through mentorship and collaboration.
Required:
- Bachelor’s degree in Food Science, Nutrition, Biology, Chemistry, or related field (professional experience may substitute).
- 5–10+ years in food manufacturing regulatory affairs, with strong experience in healthcare/nutrition claims, labeling, technical documentation, and customer interfacing.
- Deep knowledge of FDA, FTC, and relevant regulations; proven track record substantiating claims and ensuring compliance.
- Excellent project management skills—able to juggle multiple priorities in a fast‑paced environment with short timelines.
- Strong analytical/problem‑solving mindset, attention to detail, and creativity in developing compliant solutions.
- Superior written/verbal communication and interpersonal skills for cross‑functional influence (no formal authority needed).
- Proficiency with Microsoft Office and regulatory tools; detail‑oriented and quality‑focused.
Preferred:
- International regulatory compliance experience (a strong plus for global exposure).
- Experience in a manufacturing or co‑packing environment with healthcare/medical nutrition products.
If you're ready to leverage your regulatory expertise in a role that offers real strategic influence, competitive pay, and the stability of a respected industry leader—no travel required—let’s connect. This is more than compliance; it's about enabling safe, innovative products that reach millions.
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