Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Springfield
Posted on: November 19, 2024
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Job Description:
A company is looking for a Senior Regulatory Affairs Specialist
to manage the lifecycle of OEM products and ensure regulatory
compliance.
Key Responsibilities
Coordinate and prepare document packages for regulatory submissions
and internal audits
Lead the compilation of materials for submissions, license
renewals, and annual registrations
Recommend changes for regulatory compliance in labeling,
manufacturing, and clinical protocols
Required Qualifications
Bachelor's degree with 4+ years of experience in regulatory affairs
or an advanced degree with 2+ years of experience
4+ years of medical device regulatory affairs experience is
preferred
Experience with global regulatory pathways such as 510(k) and EU
MDR
Familiarity with ISO standards, particularly ISO 13485, and Quality
Management Systems (QMS)
Local to CO and willing to work in a hybrid capacity is a plus
Keywords: VirtualVocations, Hamden , Senior Regulatory Affairs Specialist, Other , Springfield, Connecticut
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