Regulatory Affairs Specialist - Aurora Illinois

Company: VirtualVocations
Location: Aurora, Illinois
Posted On: 11/07/2024

A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products.



Key Responsibilities:

Participate in product development teams to provide regulatory support
Compile technical documentation for global regulatory submissions and registrations
Review QMS and product changes for compliance with regulatory requirements


Required Qualifications:

Bachelor's Degree in STEM, Medicine, or Life Science
1-2 years of experience in medical device product development or related fields
Familiarity with medical device regulations in the US and/or EU
Knowledge of relevant standards and guidance documents (e.g., 21 CFR 820, MDR)
Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required More...

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