Senior Manager, Regulatory Affairs - Shockwave Medical

Company: Disability Solutions
Location: Santa Clara
Posted on: February 15, 2025

Job Description:

Johnson & Johnson is hiring for a Senior Manager, Regulatory Affairs - Shockwave Medical to join our team.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rShockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.\rPosition OverviewThe Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Manager, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with responsible Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Senior Manager, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.\rEssential Job Functions

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• Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units
• Manage, mentor, and develop direct reports to meet individual and company goals and objectives
• Develop, follow, and train key personnel on regulatory policies, processes and SOPs
• Develop and implement regulatory strategies and update strategy based upon regulatory changes
• Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements
• Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams
• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
• Effectively and accurately write and edit technical documents
• Review and approve R&D, quality, preclinical and clinical documentation for submission filing
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
• Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
• In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., Australia, Japan, South Korea, etc.)
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
• Effectively communicate application progress to internal stakeholders
• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
• Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
• Support product safety evaluation and reporting (e.g., PMDA/MHLW/MFDS) as required by country regulation
• Provide regulatory input for product recalls and recall communications
• In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
• Review and approve advertising and promotional materials to ensure regulatory compliance
• Evaluate, provide guidance and implement import/export requirements
• Identify emerging issues and regularly communicate status
• Provide other country specific regulatory support
• Plan and conduct meetings, create project plans and timelines, and manage projects
• Exercise good and ethical judgment within policies and regulations
• Preparation and support of quality management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.)
• Perform multiple tasks concurrently with accuracy
• Other duties as assigned\r\r

Keywords: Disability Solutions, Santa Clara , Senior Manager, Regulatory Affairs - Shockwave Medical, Healthcare , Santa Clara, California