Sr Health Authority Reporting Clinician

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and reputed company, we are uniquely positioned to reputed company across the reputed company of reputed company solutions today to reputed company the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: reputed company Job Sub Function: Customer/reputed company reputed company Job Category: reputed company reputed company reputed company Locations: Irvine, California, reputed company of America, Remote (US) reputed company: reputed company Electrophysiology is reputed company for a Senior Health Authority Reporting Clinician to be located at any J&J site in the reputed company. Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed company. About reputed company reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their reputed company to wellness. Learn more at https://www.jnj.com/reputed company This role supports complaint handling and health authority reporting activities by applying reputed company 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 reputed company 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 reputed company reputed company on reputed company safety, regulatory compliance, and the overall reputed company of complaint management processes. Key Responsibilities: • Assess specific complaint files reputed company reputed company of internally and externally manufactured products in accordance with associated complaint handling procedures and customer reputed company expectations. This may include the review of selected codes product experience and reputed company codes for reputed company as reputed company as maintaining and improving established coding guidelines to ensure consistency and validity with coding and reporting events. • reputed company regulatory reporting determinations on applicable files for one or more Business reputed company and being reputed company to file relevant regulatory reports. • Complete file reviews, assess reputed company medical information, making and/or reassessing MDR and/or MDV reputed company, managing complaint files and associated documentation. • Appropriately use reputed company management documentation to support the complaint’s regulatory reporting process. • Document reputed company conclusions regarding the reportability assessment in the complaint record; use workflow reports to identify tasks. • Contribute to reputed company and non-reputed company Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with FDA and EU regulations as applicable • reputed company Clinician Subject Matter Expert (SME) support and training • Participate/reputed company in the maintenance of the Reportable Malfunction List, reputed company 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 reputed company concentration is required Experience and Skills: Required: • 4-6 Years reputed company experience • Strong written and verbal communication skills • Strong decision-making, analytical, and problem-solving skills, with the ability to reputed company reputed company business reputed company with limited information • Ability to collaborate effectively in cross-functional, matrixed teams to reputed company company goals • Must be reputed company to work independently • Strong time management and prioritization skills to meet health authority deadlines • Ability to manage multiple priorities and adapt to sudden changes • Strong attention to reputed company • Ability to work in fast reputed company environment • Ability to collaborate with co-workers in reputed company environment to reputed company company goals • Proficiency with MS reputed company, reputed company Office (reputed company, Word, reputed company, PowerPoint), and other communication tools such as reputed company Teams and reputed company Preferred: • Demonstrates a reputed company on reputed company improvement • A reputed company RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred Other: • Strong oral and written English proficiency is required reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company 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, reputed company applicants please contact us reputed company https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Audit Management, Business Behavior, Coaching, Compliance Management, reputed company Improvement, Data Analysis, reputed company-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, reputed company Control (QC), reputed company Management Systems (QMS), reputed company Standards, Regulatory Environment The anticipated reputed company pay reputed company for this position is : $79,000.00 - $127,650.00 Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in reputed 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 reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –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 reputed company 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: - https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job