Regulatory Compliance Specialist

Role: Quality Document Systems Management

Location: 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 gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!