Sr Health Authority Reporting Clinician

About this role

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.

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 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 related concentration is required

Experience and Skills: Required: • 4-6 Years related experience • Strong written and verbal communication skills • Strong decision-making, analytical, and problem-solving skills, with the ability to make sound business decisions with limited information • Ability to collaborate effectively in cross-functional, matrixed teams to achieve company goals • Must be able 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 detail • Ability to work in fast paced environment • Ability to collaborate with co-workers in a team environment to achieve company goals • Proficiency with MS Windows, Microsoft Office (Outlook, Word, Excel, PowerPoint), and other communication tools such as Microsoft Teams and Zoom

Preferred: • Demonstrates a focus on continuous improvement • A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred

Other: • Strong oral and written English proficiency is required

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 https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

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