Associate Specialist, Regulatory Affairs Operations (Surgical)

Edwards Lifesciences • Irvine, CA

12d • $59,000 - $83,000

About The Position

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelor's Degree and a minimum of 1 year related work experience or work experience based Edwards criteria
• Coursework, seminars, and/or other formal government and/or trade association training

Nice To Haves

• Bachelor's Degree in a scientific discipline
• Good knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)
• Good knowledge and understanding of global regulatory requirements for new products or product changes
• Good knowledge of new product development systems
• Proven successful project management skills
• Strong written & verbal communication skills
• Ability to work in a fast-paced environment
• Ability to develop cross-functional relationships

Responsibilities

• Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training reports, and/or dashboards
• Execute the coordination of submissions deliverables, schedule and tracking of appendices and documents
• Prepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies in collaboration with team members
• Review and/or interpret standard assessments to ensure product compliance
• Interact effectively within the regulatory affairs team in the preparation of documentation packages, supporting team and company goals and objectives
• Prepare for regulatory agency inspections and audits (e.g., track ra plans and changes, understanding requirements)

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

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