Sr Health Authority Reporting Clinician

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.comAs 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:Irvine, California, United States of America, Remote (US)Job Description:Johnson and Johnson Electrophysiology is recruiting for a Senior Health Authority Reporting Clinician to be located at any J&J site in the United States.Remote work options may be considered on a case-by-case basis and if approved by the company.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 role supports complaint handling and health authority reporting activities by applying clinical expertise, regulatory knowledge, and excellent judgment to assess reported events and determine reportability. The position partners closely with cross-functional teams to review complaint files, support adverse event evaluations, and maintain key reporting documentation for health authority reporting. The individual will also serve as a clinical subject matter expert, support audits and compliance activities, contribute to process improvements, and help train associates to ensure consistent, accurate, and compliant complaint management and health authority reporting practices. This role has a direct impact on patient safety, regulatory compliance, and the overall quality of complaint management processes.Key Responsibilities:Assess specific complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and customer quality expectations. This may include the review of selected codes product experience and patient codes for accuracy as well as maintaining and improving established coding guidelines to ensure consistency and validity with coding and reporting events.Make regulatory reporting determinations on applicable files for one or more Business Units and being able to file relevant regulatory reports.Complete file reviews, assess patient medical information, making and/or reassessing MDR and/or MDV decisions, managing complaint files and associated documentation.Appropriately use risk management documentation to support the complaint’s regulatory reporting process.Document clinical conclusions regarding the reportability assessment in the complaint record; use workflow reports to identify tasks.Contribute to Standard and non-Standard Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with FDA and EU regulations as applicableProvide Clinician Subject Matter Expert (SME) support and trainingParticipate/Lead in the maintenance of the Reportable Malfunction List, Patient Harms List and regulatory reporting tables in support of complaint management database activitiesSupport post market surveillance trending reviewsQualificationsEducation:Bachelors or equivalent degree in Biomedical Engineering, Nursing, Life Science, Health Science or other related concentration is requiredExperience and Skills:Required: 4-6 Years related experienceStrong written and verbal communication skillsStrong decision-making, analytical, and problem-solving skills, with the ability to make sound business decisions with limited informationAbility to collaborate effectively in cross-functional, matrixed teams to achieve company goalsMust be able to work independentlyStrong time management and prioritization skills to meet health authority deadlinesAbility to manage multiple priorities and adapt to sudden changesStrong attention to detailAbility to work in fast paced environmentAbility to collaborate with co-workers in a team environment to achieve company goalsProficiency with MS Windows, Microsoft Office (Outlook, Word, Excel, PowerPoint), and other communication tools such as Microsoft Teams and ZoomPreferred:Demonstrates a focus on continuous improvementA current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferredOther:Strong oral and written English proficiency is requiredJohnson & 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: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 EnvironmentThe 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 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Irvine, California, United States of America; Remote (US)Type: Full time