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.comJob Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category: Business Enablement/SupportAll Job Posting Locations: Santa Clara, California, United States of AmericaJob Description:Johnson & Johnson is hiring for a Associate Regulatory Operations Specialist – Shockwave Medical to join our team located in Santa Clara, CA.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.Position OverviewThe Associate Regulatory Operations Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data. The function of the Associate Regulatory Affairs Operations Specialist is to provide submission publishing/verification support, and Regulatory compliance support.Essential Job FunctionsArchive correspondence sent to and received from Regulatory Agencies and Notified BodySupport publishing of worldwide regulatory submissions in compliance with geography-specific regulatory requirementsSupport verification and quality review of submissions and other responses to regulatory agenciesTrack and support original and renewals of annual licenses and registrations/listings, and collect/organize/ disseminate, when required, registration renewal documentationTrack and process systems for required payments of registrations, listings, submissions, and other Regulatory-regulated expensesProvide other country specific regulatory supportNotarize business documentsProcure document authentications, legalizations, and certificationsContribute to process improvement projectsEnsure personal compliance with applicable company policies and proceduresOther duties as neededAn internal pre-identified candidate for consideration has been identified. However, all applications will be considered.RequirementsBachelor's degree or equivalent experience. Bachelor's degree in science, math, engineering, or medical fields is preferred0 - 1 years’ experience in medical device, life science, pharma industry Experience in regulatory affairs is preferredHighly proficient with MS Word, SharePoint (or equivalent), Excel, Adobe and Power Point. Proficient with Word Macros.Ability to work collaboratively in a fast-paced environment and to perform multiple tasks concurrently with accuracyFlexible with changing priorities, ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelinesOrganized, detail oriented, with good planning and time management skillsAbility to complete short- and long-term projects of moderate complexity with some guidanceExercise sound and ethical judgment within policy and regulationsAbility to think analytically with good problem-solving skillsClear and effective verbal and written communication skills with various levels of the organizationNotary Public is a plusJohnson & 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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.The anticipated base pay range for this position is : $22.66 - $36.24Additional Description for Pay Transparency: 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
