Regulatory Affairs Specialist
Company: VirtualVocations
Location: Asheville
Posted on: October 29, 2024
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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, Johnson City , Regulatory Affairs Specialist, Other , Asheville, Tennessee
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