Regulatory Compliance Specialist

- Regulatory Compliance Specialist - Stellar Consulting Solutions, LLC# Regulatory Compliance Specialist## Job DescriptionRole: Quality Document Systems ManagementLocation: Sparks, MD(Hybrid) (Tuesday to Thursday on-site)Duration: 12+Months (Contract#W2 with Medical benefits)Client: Medical### JOB DESCRIPTION* Under general supervision, responds to customer and internal requests with information and documents that meet the customer's quality / regulatory needs.* Provides on-site audit support.* Maintains existing procedures at the Quality Systems level and below.* Investigates, analyzes, and develops solutions to a variety of problems of moderate scope and complexity, while using regulations, government guidance documents, and standards, as well as policies and procedures, for guidance.* May prepare and maintain product documentation and records for ingredients and OEM products acquired from outside suppliers to support animal by-product and In-Vitro Diagnostics (IVDR) Regulation compliance.* May contribute to the maintenance of USDA and CDC Import/Transport Permits, and USDA certificates related to product import/export.* May support maintenance of EDQM TSE Certificates of Suitability* May support maintenance of AOAC-RI Certification for identified products.* May be expected to make presentations at team meetings.* May support working with government agencies and international associates to assure the required permits, certificates, and related documents concerning animal by-product regulations are in place or provided, and thereby assure the smooth import of acquired materials, export of manufactured products around the world.Requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline.Min 3 years or a combination of equivalent education and experience.Minimum Skills Required:* Bachelor's degree (BS) in a scientific, engineering, or related technical discipline is required.* Basic knowledge of quality systems regulations, ISO Quality System and Medical Device standards.* Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.* Ability to work in teams, including large multifunctional teams, and independently obtain results as required with minimal supervision. Proven ability to use initiative and drive to achieve results.* Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.* Must be Self-motivated, organized and detail oriented.* Ability to handle multiple task assignments and effectively manage time and priorities to meet deadlines.* Ability to develop work plans and manage them to meet agreed upon goals.* Skilled in Microsoft software; excellent Excel data extraction and analysis skills; SAP proficiency strongly preferred; ability to learn and master other software programs.### Desired Skills* Project Management Experience desirable.* Knowledge of Global Animal By-Product Regulations desirable.* Knowledge of USP/EP/JP desirable* Professional certification is an advantage (e.g., RAC, Six Sigma, etc.).Kindly share resume at View email address on click.appcast.io or call me at View phone number on click.appcast.io to discuss more! #J-18808-Ljbffr