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.
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
QualificationsEducation:- 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
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 Environment
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: - https://www.careers.jnj.com/employee-benefits
