Regulatory Intelligence & Corporate Affairs Specialist

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences is recruiting a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs in Irvine, CA to lead regulatory support for global compliance and liaise with international affiliates.

You will drive regulatory process improvements, monitor global regulatory changes, and advise on strategies to expedite approvals while supporting FDA device listings and state renewals.

Qualifications

• Bachelor’s degree with 3+ years regulatory affairs experience in a regulated industry.
• Master’s degree with 1+ year regulatory affairs experience in a regulated industry.
• Equivalent experience per Edwards’ criteria.

Responsibilities

• Support the implementation of regulatory process improvement projects with key stakeholders and international counterparts.
• Monitor regulatory changes globally and provide guidance on strategies and contingency planning.
• Assist on FDA device listings, establishment registrations, and California licenses renewals as needed.
• Provide regulatory guidance for global product changes and new product development from a regulatory perspective.
• Support cross-functional teams and international affiliates to comply with regulatory requirements.

Skills

Regulatory affairs knowledge

Regulatory intelligence

Communication skills

Microsoft Office

Education

Bachelor's degree

Master's degree in regulatory affairs

Tools

Microsoft Office Suite

Job description

Edwards Lifesciences is recruiting a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs in Irvine, CA to lead regulatory support for global compliance and liaise with international affiliates.

You will drive regulatory process improvements, monitor global regulatory changes, and advise on strategies to expedite approvals while supporting FDA device listings and state renewals.