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Post Market Complaint Specialist

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 <a href="https://www.jnj.com" target="_blank" rel="noopener noreferrer">jnj.com</a>As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: QualityJob Sub Function: Customer/Commercial QualityJob Category:ProfessionalAll Job Posting Locations:Danvers, Massachusetts, United States of AmericaJob Description:About MedTechFueled 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 <a href="https://www.jnj.com/medtech" target="_blank" rel="noopener noreferrer">https://www.jnj.com/medtech</a>We are searching for the best talent for Post Market Complaint Specialist. Purpose: The Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. The candidate must have experience in medical device and post-market regulations with a solid understanding of complaint handling processes and adverse event follow up. You will be responsible for:<ul><li>Responsible for operational aspects of the team including, workflow, performance and compliance</li><li>Supervises individual contributors and conducts effective performance management</li><li>Coordinates processes and Assignment of daily work for the team</li><li>Assists in the review of the use of systems to ensure document standards are maintained</li><li>Assists with implementation of process changes and procedural updates</li><li>Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.</li><li>Ensures close partnerships with upstream and downstream customers to identify risks and improvement opportunities.</li><li>Completes assessments of product complaints to determine report ability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments.</li><li>Support investigations and review of potential adverse events.</li><li>Perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary.</li><li>Process feedback letters and communications with various reporting sites.</li><li>Support investigations and review of potential adverse events.</li><li>Escalate complex complaint issues per department policies and guidelines.</li><li>May prepare and/or reviews regulatory submissions and completes international vigilance reports of adverse events as required.</li><li>Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.</li><li>Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.</li></ul>Qualifications / Requirements:· Bachelor degree or equivalent combination of education and experience with a minimum of 2+ year’s experience with data management, record keeping, and trouble shooting in Medical Device field, or other transferrable experience related to organization, technical aptitude, and data management.<ul><li>Minimum 3+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry</li><li>Bachelor’s degree; Medical device experience preferred</li><li>Demonstrated knowledge of global medical device and/or pharmacovigilance regulations</li><li>Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803, CMDR, Meddev 2.12, etc.) (experience with PMDA highly preferred)</li><li>Excellent written, verbal & interpersonal communication skills</li><li>Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word</li><li>Approachable with a positive attitude</li><li>Critical thinker</li><li>Exceptional attention to detail in documenting events, composing clinical narratives, and editing quality documents</li><li>Demonstrated ability to manage multiple competing priorities and meet deadlines</li><li>Ability to work independently and as a team player</li><li>Experience using a global complaint handling database or quality management system e.g. ECM, Salesforce</li><li>Possess strong complaint handling experience (i.e. 21CFR 820.198)</li></ul>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, external applicants please contact us via <a href="https://www.jnj.com/contact-us/careers" target="_blank" rel="noopener noreferrer">https://www.jnj.com/contact-us/careers</a>. Internal employees contact AskGS to be directed to your accommodation resource.#LI-Onsite Required Skills: Preferred Skills:Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment The anticipated base pay range for this position is :$79,000.00 - $127,650.00Additional Description for Pay Transparency: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 Colorado –48 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 Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year Please use the following language: For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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