What are the responsibilities and job description for the Technical & Regulatory Services Manager position at ProActive Solutions USA, LLC?
Primary Objectives Of Position
The Technical and Regulatory Services Manager is responsible for leading compliance, technical support, and quality assurance efforts. This position ensures that all products meet federal regulatory standards (FDA, EPA, NSF) while also supporting clients with operational effectiveness in sanitation, food safety, and quality. This position will guide research and development (R&D) efforts for product improvement and new product development while providing technical support for troubleshooting and ensuring product quality. The manager will collaborate across departments—working with R&D, production, sales, and distribution—to identify and resolve issues, improve processes, and support clients in adhering to regulatory and quality standards.
Essential Functions And Accountability
Regulatory Compliance & Reporting:
The Technical and Regulatory Services Manager is responsible for leading compliance, technical support, and quality assurance efforts. This position ensures that all products meet federal regulatory standards (FDA, EPA, NSF) while also supporting clients with operational effectiveness in sanitation, food safety, and quality. This position will guide research and development (R&D) efforts for product improvement and new product development while providing technical support for troubleshooting and ensuring product quality. The manager will collaborate across departments—working with R&D, production, sales, and distribution—to identify and resolve issues, improve processes, and support clients in adhering to regulatory and quality standards.
Essential Functions And Accountability
Regulatory Compliance & Reporting:
- Ensure adherence to FDA, EPA, and NSF regulations across all products.
- Manage FDA reporting, including stability testing, FDA submissions, facility registrations, and product registrations.
- Perform audits (FDA, NSF, EPA) and maintain regulatory records.
- Create and maintain SOPs for product development, SSOPs, and quality control.
- Provide technical guidance on sanitation, food safety, and quality issues.
- Conduct sanitation and food safety audits for customers to ensure compliance with standards like GMP and HACCP.
- Troubleshoot equipment and microbiological issues, offering technical advice on chemical and sanitation practices.
- Evaluate and improve operational practices and processes for client production facilities.
- Perform quality control testing on finished and experimental products to ensure they meet regulatory and company standards.
- Oversee the implementation of quality improvement tools and techniques to meet key requirements.
- Monitor production and resolve quality issues in collaboration with the production department.
- Manage raw materials, finished goods, and packaging materials for quality compliance.
- Lead R&D projects focused on enhancing product performance and developing new applications and products.
- Manage lab operations, including maintaining inventory, sampling, and conducting analytical testing.
- Collaborate with departments to implement new product introductions and processes.
- Support the design and analysis of experiments for new and existing products.
- Work with Sales, Marketing, and Operations to ensure client satisfaction with technical services.
- Provide training and support to clients and production personnel on quality and safety procedures.
- Assist clients in maintaining clean, food-safe production environments.
- Travel (up to 50% overnight) to customer sites for audits, troubleshooting, and technical support.
- Regular attendance during scheduled work time.
- Perform other duties as assigned.