Regulatory Affairs Specialist, Corporate Regulatory
$74k - $104kEdwards Lifesciences Corp.
Edwards Lifesciences seeks a Regulatory Affairs Specialist to support corporate regulatory compliance and process improvements across global operations. The role involves analyzing regulatory changes, managing device listings and registrations, and collaborating with cross-functional teams to accelerate market access.
Responsibilities
- Support regulatory process improvement projects with stakeholders across business units
- Monitor and analyze regulatory changes to identify early impacts on business globally
- Provide guidance on regulatory strategies and compliance requirements worldwide
- Assist with FDA device listings, establishment registrations, and state licensing
- Support implementation of regulatory changes across business units and international affiliates
Requirements
- Bachelor's degree plus 3+ years regulatory affairs experience in highly regulated industry
- Master's degree plus 1+ year regulatory affairs experience alternatively
- Knowledge of medical device regulations and Class II/III device requirements
- Understanding of global regulatory requirements for new products and changes
- Strong written and verbal communication skills across international contexts
- Proficiency in Microsoft Office Suite applications
Compensation: $74,000-$104,000 base
Vacancy posted 10 days ago
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