Senior Specialist, Regulatory Affairs THV
Edwards Lifesciences · Irvine, CA +1 more
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Role summary
Edwards Lifesciences seeks a Senior Specialist in Regulatory Affairs for its Transcatheter Heart Valve business unit. The role involves guiding innovative heart valve technologies through domestic and international regulatory pathways, reviewing product documentation for compliance, and preparing submissions to global agencies. Requires a bachelor's degree plus five years of relevant regulatory experience, with preference for scientific background and expertise in Class II/III medical device regulations.
What they're looking for
- Bachelor's degree with minimum 5 years regulatory affairs experience or equivalent
- Formal training in government regulations or trade association standards
- Experience preparing domestic and international medical device submissions
- Knowledge of global medical device regulations for Class II and III devices
- Understanding of international regulatory requirements and new product development systems
- Scientific discipline degree preferred
What you'll be doing
- Represent regulatory function on development teams and advise on regulatory requirements and conflict resolution
- Review and approve technical documentation for regulatory compliance and accuracy
- Prepare and oversee regulatory submission packages for global agencies including IDEs, PMAs, and 510(k)s
- Monitor global regulations and assess impact on assigned projects
- Track submission timelines and milestone achievements; support agency interactions
Privacy & handoff
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