Regulatory Affairs Specialist, Corporate Regulatory

Edwards Lifesciences•Irvine, CA

10d•$74,000 - $104,000

About The Position

The Regulatory Affairs Specialist provides regulatory support and leadership to Edwards Lifesciences’ Corporate Regulatory Affairs team and cross-functional teams. The role contributes a Regulatory perspective to global Regulatory Compliance and supports solutions that enable patient access to life-saving products and therapies. It includes global interactions and support for process improvements, regulatory intelligence, compliance, and worldwide market access.

Requirements

Bachelor’s degree and at least three years of Regulatory Affairs experience within a highly regulated industry, or a master’s degree and at least one year of such experience; equivalent work experience may qualify based on Edwards’ criteria.

Nice To Haves

Degree in a scientific discipline.
Experience in the medical device, pharmaceutical, or biotechnology industry.
ISO 13485:2016 certification, coursework, seminars, or other formal government or trade association training.
Good knowledge and understanding of global regulations relevant to medium-risk (Class II) and/or high-risk (Class III) medical devices.
Good knowledge and understanding of global regulatory requirements for new products or product changes.
Good knowledge of new product development systems.
Good written and verbal communication skills with people of various international backgrounds, and good interpersonal relationship skills.
Proven expertise in Microsoft Office Suite, including Word, PowerPoint, and Excel.

Responsibilities

Support regulatory process improvement projects with stakeholders across business units and international counterparts to accelerate market access and ensure compliance.
Support Regulatory Intelligence and Standards Management programs by identifying, monitoring, and analyzing regulatory changes that may affect Edwards’ global business.
Gather information to guide strategies and contingency planning for worldwide regulatory requirements, assess proposed and current global regulations, and suggest ways to expedite approvals.
Assist Business Unit Regulatory Affairs and functional teams in implementing regulatory changes.
Assist with process improvement and remediation projects and responses from international affiliates.
Support FDA device listings, establishment registrations, and State of California Manufacturing Renewal Licenses as needed.
Support initiatives related to compliance with regulatory requirements.
Provide support to the supervisor as needed.