Regulatory Affairs Manager
Company: VirtualVocations
Location: Pasadena
Posted on: November 1, 2024
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Job Description:
A company is looking for a Regulatory Affairs Manager to oversee
regulatory initiatives for implant and prosthetic solutions.
Key Responsibilities:
Develop and implement regulatory strategies for global medical
device clearances and approvals
Manage regulatory submissions and communications with FDA and EU
notified bodies
Provide regulatory guidance to cross-functional teams throughout
the product lifecycle
Required Qualifications:
Bachelor's degree in life sciences, regulatory affairs, or a
related discipline
5+ years of experience in regulatory affairs, preferably in the
medical device industry
In-depth knowledge of FDA and international regulations (e.g., EN
ISO 13485, EU MDR)
Regulatory Certification (such as RAC) or a Master's degree in a
scientific discipline is a plus
Proficiency with regulatory software and Microsoft Office Suite
Keywords: VirtualVocations, Port Arthur , Regulatory Affairs Manager, Executive , Pasadena, Texas
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