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:** Danvers, Massachusetts, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **We are searching for the best talent for** **Manager, Complaint Handling to be located at Danvers, MA.** Remote work options may be considered on a case-by-case basis and if approved by the Company. The Manager, Complaint Handling reports directly to the Director, Post Market Engineering and oversees activities related to the complaint handling process and / or regulatory reporting process. This role will provide direction to individuals who receive and investigate product complaints. They will follow established global regulations for complaint handling and prepare/assemble complaint information for regulatory inquiries. This person will provide support during inspections by regulatory bodies and ensure appropriate and timely global medical device reporting. **Key Responsibilities** : + Oversee global complaint processing in compliance with FDA, Health Canada and EU MDR Quality System Regulations and country specific vigilance regulations. + Manage Complaint Handling group including performance appraisals and development opportunities. + Direct the timely in-flow of customer complaints and expedient processing and closure. + Responsible for oversight of Adverse Event reporting program to ensure compliance. + Responsible for oversight of the transmission of ROW incidents to the local contact for vigilance. + Support additional information requests from global regulatory agencies. + Define reports/dashboards to identify delinquency or backlog in all aspects of the complaint handling process. + Identify process improvement opportunities to enhance surveillance and to increase efficiency. + Collaborate with field-based teams and customer support center representatives to drive improvement of incoming complaint information. + Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations. + Strong analytical skills including trend and statistical analysis, interpersonal, and management skills. + Perform other duties as required. **Qualifications** **Education** + A minimum of a bachelor’s degree is required. Focus degree in Engineering and/or Science is preferred. **Experience / Skills** **Required:** + A minimum of 6 years’ experience in medical devices with a minimum of 3 years of experience in post market surveillance. + Minimum of 3 years of people management experience + Demonstrated successful project management. + Strong leadership skills to engage the team, inspire high quality, timely work, and instill a spirit of continuous improvement. + Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR. + Demonstrated ability to implement and maintain accurate documentation consistent with applicable quality standards. + Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability. + Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics. **Preferred:** + Experience with MDR/vigilance reporting globally + Experience with FDA audits in both a front and backroom capacity. **Other:** + This position may require up to a 10% of domestic and/or international travel. 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 & 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. **The anticipated base pay range for this position is :** $100,000 to $172,500 Additional Description for Pay Transparency: 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits