Principal Regulatory Affairs Specialist- Shockwave Medical

Johnson & Johnson•Santa Clara, CA

6d•Remote

About The Position

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/. 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

Requirements

University/Bachelor's degree or equivalent, master’s 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 & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with internal and external colleagues

Responsibilities

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.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
Company’s consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program
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