Senior Health Authority Reporting 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 jnj.com 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: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for a Senior Health Authority Reporting Specialist! This position can be located at any US J&J location. Position Summary: This job description covers the purpose, responsibilities, skill sets, and associated training & education required for the Health Authority Reporting Specialist. The purpose of the Health Authority Reporting Specialist is to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support. Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests. Key Responsibilities: Demonstrate world class customer support and maintain knowledge of relevant Operating Company’s products and services Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include assigning product experience and patient codes. Utilize MD Workflow reports to identify tasks and manage common Email inboxes Make regulatory reporting determinations on applicable files for one or more Business Units. Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint files activities. File Medwatch report forms within required timelines as applicable File MDVs in accordance to EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable Create and/or forward additional information follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable Manage Standard and non-Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable Lead support for regulatory additional information requests and actively supporting compliance audits Lead/ support audit and compliance review processes as needed Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures Lead assigned projects towards desired business outcomes Lead the onboarding training of new associates and/or existing associates learning a new product Lead in escalation process as required Partner with and influence stakeholders both internally and externally to drive needed change and/or execution of complaint related matters Responsible for communicating business related issues or opportunities to next management level Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Qualifications: Education: Completed apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor’s Degree or equivalent experience Required: 4-6 Years related experience is desirable (A combination of experience and Administration education can be allowed) Knowledge of applicable quality, FDA (Food & Drug); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements Knowledge of human anatomy, medical terminology, and products of applicable Business Units Strong written and verbal communication skills. Fluent spoken/written Englis. Strong decision-making skills – able to make sound business decisions with sometimes limited information Ability to work in a cross-functional and matrix environment Ability to work independently Continuous Improvement focus Time management. Ability to handle multiple priorities/ sudden changes in priorities Ability to work in stressful/fast paced environment Ability to work and interact with co-workers to accomplish company goals in a team environment Analytical/Problem Solving Skills Ability to learn Strong attention to detail Other: This position may require up to 10% of 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, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: 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)). 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 For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information