Cardinal Health · 1 week ago

Principal Regulatory Affairs Specialist - Nationwide

United States

Full-time

Remote

Senior Level, Lead/Staff

$80K/yr - $114K/yr

5+ years exp

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Responsibilities

Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.

Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.

Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution

Review design control documents including documents associated with design inputs and design outputs

Review product labeling for compliance with global labeling regulations

Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business

Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies

Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc.

Development and implementation of regulatory procedures and SOPs

Qualification

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Regulatory Affairs ExperienceMedical Device RegulationsGlobal Product RegistrationsRegulatory IntelligenceProject Management