Regulatory Affairs Specialist

Company: VirtualVocations
Location: Asheville
Posted on: October 29, 2024

Job Description:

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

Keywords: VirtualVocations, Rock Hill , Regulatory Affairs Specialist, Other , Asheville, South Carolina

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