771 Commerce Drive
Venice,
FL
34292
US
Posted: 03/22/2023
2023-03-22
2023-04-24
Employment Type:
Direct Hire/Perm
Job Category: Quality and Compliance
Job Number: 553477
Is job remote?: No
Country: United States
Job Description
Job Title: Director of Regulatory Compliance
Employment Type: Permanent
Client Location: Venice, FL - On-site
Salary: $60,000 - $120,000/annually - Based on experience
Planet Technology is seeking a Director of Regulatory Compliance for our client.
JOB SUMMARY:
The Director of Regulatory Compliance will help support regulatory and compliance of all the current product line, assist with new product development, claim substantiation and stability protocols, and work with sales teams to increase distribution throughout the USA and international countries by facilitating product registrations. Maintain and review hazard analysis and critical control points as well as the food safety program.
ESSENTIAL FUNCTIONS (other duties as required):
- Review scientific journals for substantiation of ingredients and product marketing claims.
- Create formula/product specific documentation for product registrations.
- Create and maintain product stability protocols.
- Submit and maintain product certifications (Non-GMO, Kosher, etc.).
- Work with Sales teams to submit detailed formula information for private label opportunities.
- Create documents that satisfy specific country requirements for product registrations necessary for international distribution.
- Create and maintain product dossiers.
- Create and maintain formula, component and finished product specifications.
- Submit products for testing and review & analyze data.
- Write DSHEA content that can be utilized for labels, spec sheets, marketing materials, websites, etc.
- Review, revise and approve of labels and marketing material that are DSHEA compliant.
- Answer product-related questions received by Customer Success and Sales teams.
- Review customer complaints, assist in performing investigations and follow-up with consumers.
- Assist in OOS (out of specification) investigations.
- Assist in quality functions.
- Participate in training staff on DSHEA compliance.
- Organize and prioritize department projects.
- Participate in company cGMP audits for regulatory compliance.
- Reviews annual training and make sure it is up to date and in compliance.
- Ensures all staff have completed annual training.
- Member of Safety Committee.
- Adhere to all client policies, procedures, safety rules and regulations.
- Participate in Performance Improvement and safety initiatives, including job related and annual training(s), i.e., cGMP.
Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
COMPETENCIES:
- Excellent interpersonal communication skills and multitasking ability.
- Skilled writer & proofreader.
- Must have the ability to work in a fast-paced environment.
- Strong attention to detail.
- Effective organizer.
- Must be able to work independently.
- Familiarity with analytical chemistry.
- Must be proficient in Microsoft Office including Word, Excel, Outlook and Adobe.
- Demonstrated ability to be an individual contributor or work in team-based environment.
- Knowledge of the HACCP-based Food Safety Codes
- Knowledge in the Global Food Safety Initiative (GFSI) requirement is a plus
REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor’s degree in science discipline.
- Knowledge and experience with FDA regulations including DSHEA required.
- HACCP-based Food Safety Codes certification
PREFERRED EDUCATION AND EXPERIENCE:
- Knowledge and experience with 21 CFR 111 a plus
- Knowledge in the Global Food Safety Initiative (GFSI) requirement is a plus
- Global labeling code.
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