Regulatory & Quality Support Specialist (IVD/Biologics)

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

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.