Principal Regulatory Affairs Specialist- Shockwave Medical

Principal Regulatory Affairs Specialist- Shockwave Medical J&J Family of Companies•Augusta, GA, US Principal Regulatory Affairs Specialist- Shockwave Medical Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist- Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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. The Principal Specialist, Product Stewardship: Serves as the primary liaison between the J&J Product Stewardship team and Shockwave stakeholders (including R&D, Supply Chain, Quality, Regulatory Affairs, Finance, Packaging, Marketing, and others as required) with regards to product stewardship programs, helping to manage business risk and institutionalize product stewardship programs. Supports global Product Stewardship activities associated with the following, and others as required:Global REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements Global Restriction of Hazardous Substances (RoHS) requirements Global Battery Regulations Global Packaging and Packaging Waste Regulations Other applicable environmental regulations under the purview of Product Stewardship Develops systems for intake, assessment, and tracking of worldwide environmental product and packaging compliance requirements. Liaises with new product development teams to ensure product stewardship and environmental sustainability requirements are considered during new product design and launch. Works with appropriate internal and external stakeholders to ensure worldwide reporting obligations related to environmental and packaging requirements are met. Creates and/or updates procedures to reflect changing environmental requirements, ensuring processes support the mining of data necessary to demonstrate compliance. Advises management on trends in the global regulatory environment that may impact current or future Shockwave business. Manages and provides updates on critical tasks for ongoing projects. Develops skill set to enable value-added individual contributions working under moderate supervision. Implements methods for planning, directing, coordinating, and controlling Product Stewardship regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations and stewardship guidance to ensure compliance with regulatory/government standards and expectations. Requirements: University/Bachelors degree or equivalent, masters degree preferred, with emphasis on chemistry, engineering, or related sciences At least 8 years experience in Regulatory Affairs, including 3+ years working with environmental sustainability and packaging regulations Familiarity and knowledge of global product stewardship regulations (e.g., REACH, RoHS, Batteries, PPWR, CA Prop 65, WEEE, etc.) Clear and effective verbal and written communication skills with diverse audiences and personnel Ability to think analytically with excellent problem-solving skills Demonstrated ability to strategize, create, implement and execute a program across multiple departments Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy, and all deadlines are met Applies Johnson & Johnsons Credo and Leadership Imperatives in day-to-day interactions with internal and external colleagues The anticipated base pay range for this position is: US: $105,000 - $169,050 / Bay Area: $121,000 - $194,350 Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours #J-18808-Ljbffr