Professional Support-30543

OLSA Resources, Inc.; Des Plaines (IL); On-site; USD 50,000 - 70,000; Full time

Job summary

A regulatory compliance firm is seeking a professional to implement and maintain quality systems while preparing U.S. regulatory submissions. The ideal candidate will have knowledge of IVD regulations, with a Bachelor's Degree in a technical discipline, and a preference for 1-2 years of regulatory experience in in-vitro diagnostics. This role is crucial for ensuring compliance and supporting the manufacturing process with regulatory directives.

Qualifications

• Knowledge of regulations and standards affecting IVDs and/or Biologics.
• Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics.
• RAPS Certification preferred.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Supports manufacturing day-to-day activities for change control.
• Prepares U.S. regulatory submissions and registration documents.

Skills

Knowledge of IVD regulations

Regulatory submission preparation

Technical knowledge in biology/chemistry

Education

Bachelor's Degree in a technical discipline

Job description

Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory direction on team activities. Applies basic regulatory understanding to support of product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Knowledge of regulations and standards affecting IVDs and/or Biologics. Bachelor's Degree preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc. Minimum 0 years regulatory experience required. Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics. RAPS Certification preferred.