Health Information Specialist

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 #J-18808-Ljbffr