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: People LeaderAll Job Posting Locations: Santa Clara, California, United States of AmericaJob Description:Johnson & Johnson is hiring for a Manager, Regulatory Affairs – 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.Position OverviewThe Regulatory Affairs Manager works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. With guidance from responsible Regulatory Affairs Management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Regulatory Affairs Manager properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.Essential Job FunctionsCollaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational unitsManage, mentor, and develop direct reports to meet individual and company goals and objectivesDevelop and follow regulatory policies, processes and SOPs and may train key personnel on themDevelop regulatory strategies and update strategy based upon regulatory changesDetermine submission and approval requirements in assigned geographiesProvide strategic input and technical guidance on regulatory requirements to product development and operations teamsWork with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)Review and approve R&D, quality, preclinical and clinical documentation for submission filingIn collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvalsCommunicate application progress to internal stakeholdersEffectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirementsDirect the process for preparation and maintaining annual licenses, registrations/listings for assigned geographiesSupport product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulationProvide regulatory input for product recalls and recall communicationsIn collaboration with Regulatory Management, develop, communicate, and build consensus for regulatory goals that are in alignment with the companyReview and approve advertising and promotional materials to ensure regulatory complianceEvaluate import/export requirementsIdentify emerging issuesProvide other country specific regulatory supportEffectively and accurately write and edit technical documentsPlan and conduct meetings, create project plans and timelines, and manage projectsExercise good and ethical judgment within policy and regulationsPerform multiple tasks concurrently with accuracyProvide guidance to functional groups in the development of relevant data to complete a regulatory submissionOther duties as assignedRequirementsMinimum 10 years’ experience preferred in a regulated healthcare industry with Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferredSome medical device software engineering background or experience is preferred.Working knowledge of applicable domestic and international regulatory guidelines, policies and regulationsExperience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, etc.Ability to outline sound regulatory strategy in alignment with regulations and business prioritiesThink analytically with excellent problem-solving skillsEffectively negotiate internally and externally with regulatory agenciesClear and effective verbal and written communication skills with diverse audiences and personnelKnowledge of business functions and cross group dependencies/ relationships.Leadership of functional groups in the development of relevant data to complete a regulatory submissionAble to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issuesAble to effectively lead direct reports while demonstrating flexibility to changing environments.Ability to work collaboratively in a fast-paced environment while managing multiple prioritiesProficient in MS Word, Excel and Power PointJohnson & 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 : US: $115,000 - $197,000 / Bay Area: $141,000 - $227,700Additional 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
