Senior Manager, Regulatory Affairs TMTT

Edwards Lifesciences • Irvine, CA

3d • $145,000 - $205,000

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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: Manage rest of world (all geographies outside the US & EU). Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues. Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy Partner with regional regulatory affairs teams to develop strategies, define requirements and execute on rest of world submissions. Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support Develop strategies and contingency plans for projects, including those that are most complex and challenging May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input on the development of standards/regulations that affect the Medical Device industry May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy

Requirements

• Bachelor's Degree and a minimum of 10 years related experience or equivalent work experience based on Edwards criteria
• Demonstrated track record of people management
• Experience working in a medical device, pharmaceutical or RA company
• Ability to travel up to 30% internationally

Nice To Haves

• Master's Degree and a minimum of 8 years related experience or equivalent work experience based on Edwards criteria
• Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices
• Expert knowledge and understanding of global regulatory requirements for new products or product changes
• Expert knowledge of new product development systems
• Represents leadership on projects within a specific area interfacing with project managers and regulatory affairs team
• Consult in project setting within specific regulatory affairs area
• Provides regulatory affairs leadership to outsourcing partners on a task level, and may participate on small scale RFP
• Proven successful project management leadership skills
• Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

Responsibilities

• Manage rest of world (all geographies outside the US & EU).
• Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables.
• Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
• Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy
• Partner with regional regulatory affairs teams to develop strategies, define requirements and execute on rest of world submissions.
• Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders
• Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives.
• Includes preparation and oversight of larger documentation packages for submission to regulatory agencies.
• Track timelines and documents for inclusion in regulatory submissions.
• Interact with regulatory agencies as part of submission review and on-site audit support
• Develop strategies and contingency plans for projects, including those that are most complex and challenging
• May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
• May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input on the development of standards/regulations that affect the Medical Device industry
• May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy

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