Senior Health Authority Reporting Clinician

Johnson & Johnson

Senior clinician managing complaint assessments and health authority reporting for Johnson & Johnson MedTech. Supporting regulatory compliance, patient safety, audits, training, and post-market surveillance.

Posted 8/17/2026full-timeIrvine • California • 🇺🇸 United StatesSenior💰 $79,000 - $127,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in complaint handling procedures, regulatory reporting, and clinical assessments within the biomedical and healthcare sectors. Proficient in collaborating with cross-functional teams and managing multiple priorities while ensuring compliance with health authority regulations.

Highest-signal resume keywords

Regulatory ReportingComplaint Handling ProceduresClinical AssessmentsCross-Functional CollaborationBiomedical Engineering

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Reporting DeterminationsMDR and MDV Decision MakingRisk Management DocumentationPatient Medical Information AssessmentCoding Guidelines Review

Soft Skills

Strong Written CommunicationAnalytical SkillsProblem-Solving SkillsTime ManagementAttention to Detail

Tools & Technologies

MS WindowsMicrosoft OfficeMicrosoft TeamsZoom

Certifications & Qualifications

Current RN LicenseAdvanced Practicing License

Industry Keywords

Biomedical EngineeringLife ScienceHealth SciencePost-Market SurveillanceHealth Authority Regulations

About the role

Key responsibilities & impact

Assess complaint files for internally and externally manufactured products according to complaint handling procedures and customer quality expectations
Review product experience and patient codes for accuracy and maintain or improve coding guidelines
Make regulatory reporting determinations and file relevant regulatory reports for applicable Business Units
Complete file reviews and assess patient medical information
Make or reassess MDR and/or MDV decisions and manage complaint files and documentation
Use risk management documentation to support the complaint regulatory reporting process
Document clinical conclusions regarding reportability assessments and use workflow reports to identify tasks
Contribute to Standard and non-Standard Health Authority Requests, including justifications for non-reporting under FDA and EU regulations
Provide Clinician Subject Matter Expert support and training
Participate in or lead maintenance of the Reportable Malfunction List, Patient Harms List, and regulatory reporting tables
Support post-market surveillance trending reviews
Partner with cross-functional teams on complaint reviews, adverse event evaluations, audits, compliance, and process improvements

Requirements

What you’ll need

Bachelor's or equivalent degree in Biomedical Engineering, Nursing, Life Science, Health Science, or another related concentration
4–6 years of related experience
Strong written and verbal communication skills
Strong decision-making, analytical, and problem-solving skills
Ability to collaborate effectively in cross-functional, matrixed teams
Ability 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 a fast-paced environment
Ability to collaborate with co-workers in a team environment
Proficiency with MS Windows, Microsoft Office (Outlook, Word, Excel, PowerPoint), Microsoft Teams, Zoom, and other communication tools
Strong oral and written English proficiency required
Current RN license or advanced practicing license (PA, APRN, etc.) strongly preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and applicant accommodations