What are the responsibilities and job description for the Regulatory Affairs Associate position at First Quality?
The Regulatory Affairs Associate is responsible for coordinating and documenting review of packaging and marketing artwork, customer product safety requests, supports maintenance of regulatory systems to monitor technical data from our supplier base. This position is responsible for the regulatory review of artwork and maintenance of related processes to ensure compliance with current and future regulations and customer requirements. May support project teams and assist in compiling and preparing technical documentation for submission to regulatory agencies, customers, legal counsel, and third-party labs and consultants.
- Understands regulations applicable to medical devices, cosmetics, and consumer products.
- Reviews packaging and marketing artwork in compliance with Federal/State regulations and company policy.
- Reviews and advises on applicable labeling, product claims, training materials.
- Maintains documentation of records and substantiation for artwork review and regulatory submissions.
- Collects supplier technical data to support product and material regulatory compliance.
- Supports maintenance of ingredient databases, raw material specification safety information, procedures, and applicable ingredient labeling for artwork review.
- Sets up and maintain files and prepares controlled communications with both internal and external personnel as required.
- Coordinates and prepares submissions and reports to customers and regulatory authorities.
- Supports tools that manage Registrations, Submissions, Notifications of Change among others.
- Coordinates information and sample collection to help support certifications and safety substantiation.
- Submits and follows up on regulatory driven purchase requisitions and purchase orders.
- Prepares documentation for USMCA certifications as requested.
Performs other duties and assignments as necessary.
First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.
First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.
