Senior Analyst, Project Management, Regulatory Affairs Surgical

Edwards Lifesciences • Irvine, CA

1d • $90,000 - $127,000

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. How you'll make an impact: Lead the execution of tasks as defined in the project management plan and actively manage project risk. Determine and discern detailed requirements on mid-to-large scale projects to establish the project deliverables and develop the project management plan, and manage changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes. Determine and discern detailed requirements on submissions deliverables, schedule and tracking of appendices and documents for mid-to-large regulatory affairs projects Lead various regulatory affairs improvement initiatives, including submission standardization, regulatory systems, and standards management. Develop procedures, checklists, templates supporting submission quality and best practices Prepare for and provide guidance on regulatory agency inspections and audits (e.g., track ra plans and changes, understanding requirements) Assess project performance to monitor the progress of the project, identify and quantify variances, perform required corrective actions and communicate to all stakeholders Establish and coordinate team members and stakeholder relationships, expectations, and communications

Requirements

• Bachelor's Degree & a minimum of 5 years experience hands on experience managing mid-to-large scale projects OR equivalent based on Edwards criteria

Nice To Haves

• Project Management Professional (PMP) Certified
• Notary Public with active license, authorized to verify and authenticate legal documents, contracts, and signatures to ensure compliance and accuracy
• Regulatory Affairs project management experience
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Substantial understanding and knowledge of principles, theories, and concepts relevant to managing small-to-mid-scale project plans
• Ability to adapt to rapidly changing environment
• Strong problem-solving, organizational, analytical and critical thinking skills

Responsibilities

• Lead the execution of tasks as defined in the project management plan and actively manage project risk.
• Determine and discern detailed requirements on mid-to-large scale projects to establish the project deliverables and develop the project management plan, and manage changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes.
• Determine and discern detailed requirements on submissions deliverables, schedule and tracking of appendices and documents for mid-to-large regulatory affairs projects
• Lead various regulatory affairs improvement initiatives, including submission standardization, regulatory systems, and standards management.
• Develop procedures, checklists, templates supporting submission quality and best practices
• Prepare for and provide guidance on regulatory agency inspections and audits (e.g., track ra plans and changes, understanding requirements)
• Assess project performance to monitor the progress of the project, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
• Establish and coordinate team members and stakeholder relationships, expectations, and communications

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: Mid Level
• Number of Employees: 5,001-10,000 employees