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 **Job Function:** Quality **Job Sub** **Function:** Customer/Commercial Quality **Job Category:** Professional **All Job Posting Locations:** Santa Clara, California, United States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Complaints Specialist** **– Shockwave Medica** l to join our team located in **Santa Clara, CA.** 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. **Position Overview** In compliance with FDA, European MDD/MDR & other International Regulations, the Sr. Complaints Specialist will perform work under general supervision. General scope of this position is to ensure compliance to Complaints and Post Market Surveillance System, complaint initiation, assessment of regulatory reporting, investigation, filing regulatory reports, maintaining quality compliance, assisting with drafting periodic reports, and ensuring quality metrics are achieved. This position requires frequent use and proficient knowledge of industry practices, techniques, and standards. **Essential Job Functions** + Ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations. + Initiate complaints and ensure all required information are gathered and added to the complaints file in an accurate and timely manner. + Review adverse event reporting determinations against domestic and international regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA etc.) + Accurately assess risk and escalate high risk incidents to management. + Complete reportability assessment and route for approvals in a timely manner. + Complete and submit Vigilance Reporting, MDR and other country specific regulatory reporting documents in an accurate and timely manner. + Determine if an investigation is necessary. Oversee and provide direct support of technical evaluations and investigational tasks required for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, whether formal device investigation is necessary. + Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review. + Support service & repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted. + Assist in closing complaints in a timely and accurate manner. + Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint reporting or complaint completion.) + Provide guidance to other team members on dealing with potentially reportable events or complaints with inadequate information. + Ensure complaints are prioritized based on patient, product, and compliance risk. + Provide routine feedback to the Manager regarding the Complaints Teams’ performance. + Communicate with Customers and Shockwave Medical field reps in a professional manner to gather complaint information. + Assist with training Customer and Shockwave Medical reps to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements. + Ensure Economic Operators are part of the Approved Supplier File. + Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in different geographies. + Assist with compiling quality metrics for trending purposes Assist with the development and implementation complaint event tracking and trending data collection tools. + Maintain QA related logs and databases (e.g. Complaints, Audit Findings etc.) when required. + Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc. + Support New Product and New Country Introduction + Draft/revise procedures and help implement Complaint and Post Market Surveillance system changes as needed to accommodate new product and new country introductions. + Ensure compliance to the Post Market Surveillance System. + Work cross functionally and assist in drafting, reviewing, and revising periodic reports (e.g. Clinical Evaluation Report, Periodic Safety Update Report and Post Market Surveillance Report.) + Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems. + Support Regulatory submissions by providing Post Market Surveillance data trends. + Participate in quality system activities and support internal and external audits. + Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. **Requirements** + Associate’s degree with 7+ years of related quality experience; or a Bachelor’s degree with 5+ years of experience is highly preferred. + Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices. + Related Quality System Certification is a plus. + Experience with FDA/ISO Audits, NCR, and CAPA experience. + Proficiency in data compilation, analysis, presentation, and document writing skills. + Excellent written and verbal communication skills. + Working knowledge of cGMP, QSR, ISO13485 and other applicable regulations. + The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.) + Experience with computer-based applications (MS Word, MS Excel, QAD). + Positive mentorship experience is preferred. + Strong interpersonal skills and ability to provide good customer service support. + Strong time management skills and the ability to multi-task in a fast-paced environment. + Ability to work in a fast-paced environment while managing multiple priorities. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. **Pay Transparency:** + The anticipated salary range for this position is $89,000 - $142,600 + The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. + Employees and/or eligible dependents may be 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. + Employees may be 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. + Employees are eligible for the following time off benefits: + Vacation – up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year + Holiday pay, including Floating Holidays – up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits _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_ _(ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource._ **The anticipated base pay range for this position is :** $89,000 - $142,600 Additional Description for Pay Transparency: