This job has closed.

Vensure Employer Solutions · 1 month ago

QDS Regulatory Manager

Florida, United States

Full-time

Onsite

Senior Level, Lead/Staff

12+ years exp

Vensure Employer Solutions is a leading regulatory management consulting firm specializing in the Food/Beverage, Dietary Supplement, Cosmetic, and OTC/Homeopathic industries. The QDS Regulatory Manager is responsible for project ownership and client support in regulatory compliance, including documentation preparation, auditing, and quality assurance activities.

Customer ServiceFinancial ServicesHuman ResourcesRisk Management

Responsibilities

Write, review, collect, coordinate and/or oversee projects, and prepare regulatory documentation for submission to regulatory agencies, commercial partners and/or clients, including but not limited to SOP's, ingredient and finished product specifications, quality agreements, formulation reviews, quality program design/input, HACCP/HARPC Plans, FSMA Compliance, cGMP Training, and other investigation reports, study protocols, final reports reviews and submissions as directed

Define, manage and/or execute projects and prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to regulatory plans, investigational reports, professional opinions, study protocols, final reports, and related data. Cooperate with team members on shared projects as designated to ensure efficiency in time management, execution of the work, and correctness of any deliverables or communications as designated

Maintain regulatory files/database and other systems in good order and in compliance with project or regulatory requirements

Review changes to existing product formulations and Quality Systems to help define the requirements for regulatory compliance of individual clients

Maintain regulatory and scientific excellence by keeping current knowledge of FTC, FDA, USDA and other national regulations, guidance, and standards applicable to client products upon direction and/or as experience permits

Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(es) and methodologies

Provide team and client leadership with guidance on compliance matters and regulatory operations with respect to known strategies and activities

Operate seamlessly within team in a project management-driven environment to keep all projects updated/current, reporting of billable time, and proper utilization of company software and resources to ensure traceability and accountability

Participate as needed in tradeshows, conferences, and other industry-related events

Travel as needed/permitted to client facilities or other locations in direct support of assigned projects, or other company activities

Qualification

FDA regulationsQuality AssuranceRegulatory complianceMS Office proficiencyProject managementTeam leadershipCommunication skillsProblem-solving

Required

Extensive knowledge in FDA, FTC, USDA regulations

Knowledge of FDA CFR 21 Part 11, Part 111 and Part 117

Must be able to handle multiple projects

Proficient in MS Team, Word, Excel and Adobe

BS in a scientific field is required

Minimum of 12 years' experience in Quality Assurance within the OTC industry

Preferred

MS, Ph.D

Food & Beverage, Dietary Supplement, Cosmetic and/or Homeopathic industries as a bonus

Company

Vensure Employer Solutions

Vensure Employer Solutions is a privately owned professional employer organization (PEO) headquartered in Chandler, Arizona, with offices in Sarasota, Florida, and Duluth, Georgia.

Founded in 2004

Chandler, Arizona, USA

1001-5000 employees