Senior Manager, Regulatory Affairs (Irvine, CA), Transcatheter Heart Valve

This is an exciting and unique opportunity for a regulatory affairs professional, with experience in regulatory strategy & submissions, for new product development Class III implantable devices. Here you will work with a seasoned regulatory, medical device team to play an important role in a pivotal NPD product at Edwards. You will collaborate directly with R&D engineering, and other functional areas, to provide regulatory guidance and insight throughout the NPD process. You have the understanding of the regulatory pathways and will author and submit regulatory submissions as necessary. This is a high-visibility opportunity that provides many levels of exposure to advance in your career.

Please note this is a high-engagement, office-based position on our beautiful campus in Irvine, California. We will support relocation assistance funds and services within the United States, if needed, for a qualified candidate who wants to relocate to a commutable distance from the Edwards main campus.

More information on our campus and culture here:

https://www.edwards.com/gb/careers/locations/irvine

The Senior Manager of Regulatory Affairs (THV) serves as regulatory affairs lead on new product development projects and indication expansions for Transcatheter Heart Valve product platforms. You will prepare regulatory strategies and submissions and work closely with cross-functional project teams to achieve project goals such as commercial approvals and clinical trial initiation and maintenance, primarily in the US and Europe.

Key Responsibilities:

• Develop and plan multiple regulatory affairs projects and activities with accountability for successful completion of regulatory deliverables.

• Includes representing the regulatory function on 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.

• Author regulatory submissions of various complexity and interact with regulatory bodies during submission reviews.

• 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

• 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

• 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

• Other incidental duties

Education and Experience:

• Bachelor's Degree in related field PLUS 10 years of related, previous experience required

• Coursework, seminars, and/or other formal government and/or trade association training required

• Professional experience and expertise in Regulatory Affairs for Class III medical device products required

• Master's Degree or equivalent in related experience preferred

Additional Skills:

• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Excellent problem-solving, organizational, analytical and critical thinking skills

• Recognized as an expert in own area with specialized depth within the organization

• Expert knowledge and understanding of global regulations relevant to 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

• Strong leadership skills and ability to influence change

• Strict attention to detail

• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

• Ability to manage competing priorities in a fast paced environment

• 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

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

About Edwards Lifesciences LLC

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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