Principal Regulatory Affairs Specialist- Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Johnson & Johnson is hiring for aPrincipal Regulatory Affairs Specialist- Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

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