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.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: 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 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 This 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.

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 applicable Provide Clinician Subject Matter Expert (SME) support and training Participate/Lead in the maintenance of the Reportable Malfunction List, Patient Harms List and regulatory reporting tables in support of complaint management database activities Support post market surveillance trending reviews Qualifications Education: Bachelors or equivalent degree in Biomedical Engineering, Nursing, Life Science, Health Science or other