Regulatory Affairs Manager
VirtualVocationsDorchester, Massachusetts, United States30+ days ago
Job type
- Full-time
Job description
A company is looking for a Regulatory Affairs Manager.
Key Responsibilities
Maintain the Quality Management System (QMS) and ensure compliance with regulatory standards
Collaborate with cross-functional teams to design workflows that enhance quality without hindering product velocity
Lead documentation efforts and support product teams through process changes and onboarding
Required Qualifications
3+ years of experience in quality, compliance, regulatory, or technical program management
Experience with QMS systems and FDA documentation workflows
Proven ability to implement structured processes in fast-paced environments
Basic technical fluency in machine learning, product development, and system design
Experience with ISO 13485 or FDA SaMD regulations is a plus
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Regulatory Manager • Dorchester, Massachusetts, United States
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