Global Regulatory Affairs Specialist – Medical Devices (TMTT)

Edwards; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards is seeking a Regulatory Affairs professional to guide complex domestic and international product submissions within the Transcatheter Mitral and Tricuspid Therapies portfolio. You will partner with EW affiliates and cross-functional teams to ensure timely, compliant filings and align with global regulations.

The role requires a Bachelor's degree with at least five years of related experience and a solid understanding of regulatory requirements for medical devices.

Qualifications

• Bachelor's Degree & a minimum of 5 years related experience OR equivalent work experience based on Edwards criteria.
• Coursework, seminars, and/or other formal government and/or trade association training.
• Experience in preparing domestic & international product submissions.

Responsibilities

• Create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, the globe minus US, EU, Canada)
• Represent the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management
• Provide guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
• Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates

Education

Bachelor's Degree

Job description

Edwards is seeking a Regulatory Affairs professional to guide complex domestic and international product submissions within the Transcatheter Mitral and Tricuspid Therapies portfolio. You will partner with EW affiliates and cross-functional teams to ensure timely, compliant filings and align with global regulations.

The role requires a Bachelor's degree with at least five years of related experience and a solid understanding of regulatory requirements for medical devices.