Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs

Edwards Lifesciences • Irvine, CA

7h

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 support the company’s global regulatory compliance and involves global collaboration to develop solutions that help patients access life-saving products and therapies.

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 based on Edwards’ criteria may also qualify.

Nice To Haves

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

Responsibilities

• Support implementation of regulatory process improvement projects by working with stakeholders across business units and international counterparts to accelerate market access routes 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 the impact of proposed and current global regulations, and suggest ways to expedite approvals.
• Assist Business Unit Regulatory Affairs and functional teams with 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 compliance initiatives related to regulatory requirements.
• Provide support to the supervisor as needed.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees’ and their families’ diverse individual needs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level