Senior Health Authority Reporting Clinician

Jobtailor; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Jobtailor in Irvine, CA is seeking a Regulatory Quality Specialist to assess complaint files for medical devices, review product experience and patient codes, and determine health authority reporting obligations across relevant Business Units.

You will collaborate with cross-functional teams, manage multiple priorities in a fast-paced environment, and document clinical conclusions to support compliance and post-market surveillance.

Qualifications

• 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

Responsibilities

• Assess complaint files for products per complaint handling procedures and quality expectations
• Review product experience and patient codes for accuracy; maintain or improve coding guidelines
• Make regulatory reporting determinations and file regulatory reports for applicable units
• Complete file reviews and assess patient medical information
• Make or reassess MDR/MDV decisions and manage complaint files
• Use risk management documentation to support regulatory reporting
• Document clinical conclusions on reportability and use workflow reports to identify tasks
• Contribute to Health Authority requests; justify non-reporting per FDA/EU regulations
• Provide clinician SME support and training
• Maintain Reportable Malfunction List and Patient Harms List and regulatory tables
• Support post-market surveillance trending reviews
• Partner with cross-functional teams on reviews, adverse events, audits, and improvements

Skills

Regulatory Reporting

Complaint Handling

Clinical Assessments

Cross-Functional Collaboration

Biomedical Engineering

English Proficiency

Team Collaboration

Decision Making

Attention to Detail

Time Management

Independent Working

Education

Bachelor's degree in Biomedical Engineering or related field

RN License

Advanced Practicing License

Tools

MS Windows

Microsoft Office

Microsoft Teams

Zoom

Job description

• 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

• 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

Core Competencies

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 Reporting
• Complaint Handling Procedures
• Clinical Assessments
• Cross-Functional Collaboration
• Biomedical Engineering

ATS Optimization Keywords

Hard Skills

• Regulatory Reporting Determinations
• MDR and MDV Decision Making
• Risk Management Documentation
• Patient Medical Information Assessment
• Coding Guidelines Review

Soft Skills

• Strong Written Communication
• Analytical Skills
• Problem-Solving Skills
• Time Management
• Attention to Detail

Certifications & Qualifications

• Current RN License
• Advanced Practicing License

Industry Keywords

• Biomedical Engineering
• Life Science
• Health Science
• Post-Market Surveillance
• Health Authority Regulations

Tools & Technologies

• MS Windows
• Microsoft Office
• Microsoft Teams
• Zoom