Regulatory Intelligence & Corporate Affairs Specialist

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

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs Specialist in Regulatory Intelligence & Corporate Regulatory Affairs to support global regulatory compliance and cross-functional teams. The role provides a regulatory perspective to enable patient access to life-saving devices and therapies.

The candidate will engage with international counterparts, manage regulatory changes, and contribute to process improvements while aligning with business objectives.

Qualifications

• Bachelor’s degree and minimum of 3 years of Regulatory Affairs experience in a highly regulated industry OR Master’s degree with at least 1 year of Regulatory Affairs experience in a highly regulated industry.
• Experience with global medical device regulations and readiness for regulatory submissions.
• Knowledge of global Regulations relevant to medical devices (Class II/III) and product changes.

Responsibilities

• Provide regulatory support and leadership to Edwards Lifesciences’ Corporate Regulatory Affairs team and cross-functional teams.
• Assist on regulatory process improvement projects and remediation with international affiliates.
• Support FDA device listings, establishment registrations, and state licensure requirements as needed.
• Prepare guidance on regulatory strategies and contingency planning for worldwide regulatory requirements.

Education

Bachelor's degree in Regulatory Affairs or related field

Master's degree in Regulatory Affairs or related field

Tools

Microsoft Office (Word, PowerPoint, Excel)

Job description

Edwards Lifesciences is seeking a Regulatory Affairs Specialist in Regulatory Intelligence & Corporate Regulatory Affairs to support global regulatory compliance and cross-functional teams. The role provides a regulatory perspective to enable patient access to life-saving devices and therapies.

The candidate will engage with international counterparts, manage regulatory changes, and contribute to process improvements while aligning with business objectives.