Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Vista
Posted on: May 7, 2025
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Job Description:
A company is looking for a Senior Regulatory Affairs Specialist
(Remote/Flexible).
Key Responsibilities
Support regulatory approval processes for medical devices in
domestic and international markets
Assist with pre-market and post-market filings and manage
submission deliverables
Review and approve project documentation and evaluate change
assessments for compliance
Required Qualifications
B.S. / B.A. degree or a minimum of 7 years of regulatory/quality
experience in the medical device industry
Minimum 5 years of regulatory/quality experience in the medical
device industry
Knowledge of regulatory guidelines and requirements (domestic and
international)
Experience with reviewing Engineering Change Orders (ECOs) and
regulatory documentation
Understanding of relevant regulations such as 21 CFR 820, ISO
13485, and MDD/MDR
Keywords: VirtualVocations, La Puente , Senior Regulatory Affairs Specialist, Other , Vista, California
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