Senior Regulatory Affairs Specialist (Ad and Promo) - Shockwave Medical

Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist- Shockwave Medical to be located in New Brighton, MN.

At 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/.

For 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.

At Johnson & Johnson, we all belong.

Shockwave 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.

Position Overview

The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities, works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist, (Advertising/Promotion) is responsible for reviewing, editing and supporting compliance of SWMI advertising and promotional material and internal procedures/training. This individual supports decision-making for advertising and promotion regulatory activities.

Essential Job Functions

• Collaboratively interface with marketing/sales personnel and other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with SWMI commercial approvals and within established timelines.
• Maintain geography specific advertising and promotion regulatory policies, processes and SOPs and train key internal stakeholders.
• In collaboration with marketing personnel, assist RA leadership in establishing and maintaining product claims matrices for worldwide reference.
• Conduct Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance.
• Ensure that changes in product labeling are appropriately reflected in current promotions and advertising.
• Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use.
• Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and develop/implement corrective action plans for resolution of problematic issues with guidance from RA leadership.
• Identify and communicate emerging issues to RA leadership.
• Plan and conduct meetings, create project plans and timelines, and manage projects with guidance from RA leadership, when assigned.
• Exercise good and ethical judgment within policy and regulations.
• Other duties as assigned.