Global Regulatory Affairs Specialist – Medical Devices

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

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements and regulatory initiatives across multiple business units and international teams.

You will help monitor global regulatory changes, advise on strategies for expediting approvals, and assist on listings, registrations, and renewal processes. Strong communication and MS Office skills are essential, with knowledge of ISO 13485 preferred.

Qualifications

• Bachelor's degree in science with 3+ years regulatory affairs experience in a highly regulated industry OR Master's with 1+ year regulatory experience.
• Experience with global medical device regulations and ISO 13485 is preferred.

Responsibilities

• Support implementation of Regulatory process improvement projects with stakeholders across business units and international counterparts.
• Support Regulatory Intelligence and Standards Management to identify regulatory changes impacting Edwards globally.
• Assist with strategies and contingency planning for worldwide Regulatory requirements and expediting approvals.
• Assist business unit regulatory affairs and functional teams with regulatory changes.
• Support FDA device listings, establishment registrations, and California renewal licenses as needed.
• Ensure adherence to regulatory requirements and assist supervisor as needed.

Skills

Regulatory affairs

Cross-functional communication

MS Office (Word, PowerPoint, Excel)

Education

Bachelor's degree in science

Master's degree in science (optional)

Tools

Regulatory databases

Job description

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements and regulatory initiatives across multiple business units and international teams.

You will help monitor global regulatory changes, advise on strategies for expediting approvals, and assist on listings, registrations, and renewal processes. Strong communication and MS Office skills are essential, with knowledge of ISO 13485 preferred.