Health Authority Reporting Analyst

TL;DR

Health Authority Reporting Analyst (Medical Device): Review and process product complaints and manage regulatory reporting to FDA and vigilance reporting for medical devices with an accent on complaint file regulatory determinations, MedWatch/MDV submissions, and Health Authority Request handling. Focus on applying 21 CFR Part 803 and EU MDR vigilance requirements, maintaining reportable malfunction lists, and supporting compliance audits.

Location: Warsaw, IN (Hybrid 2 to 3 days a week)

Company

hirify.global is a global full-service CRO supporting clinical development and functional solutions across pharmaceutical, biotechnology, medical device, and consumer health.

What you will do

• Review, assess, process, and close complaint files in line with internal/external complaint handling procedures and CQ expectations.
• Make regulatory reporting determinations (MDR/MDV decisions) and manage complaint file activities for applicable business units.
• File MedWatch report forms within required timelines and submit MDVs in accordance with EEA, Switzerland, Turkey, and other third-country guidance.
• Maintain reportable malfunction lists and regulatory reporting tables supporting complaint management database activities.
• Manage Standard Health Authority Requests, including justifications for non-reporting, and support additional information requests and compliance audits.
• Support onboarding/training and participate in escalation, projects, and audit/compliance review processes as needed.

Requirements

• Fluent spoken and written English required.
• 2–4 years of related experience is desirable (or an equivalent combination of education and experience).
• Knowledge of applicable quality requirements, FDA requirements (including 21 CFR Part 803), medical device directives/regulations, and ISO requirements.
• Knowledge of human anatomy, medical terminology, and medical device products for applicable business units.
• Strong written/verbal communication, decision-making, analytical/problem-solving, attention to detail, and time management skills.
• Ability to work independently and in a cross-functional/matrix environment.

Culture & Benefits

• Hybrid schedule: work from Warsaw, IN office 2–3 days per week.
• World-class customer support expectations and continuous improvement focus.
• Training and onboarding for new associates and ongoing learning for new products.
• Compliance-first environment with support for audits and regulatory readiness.

Hiring process

• Interviews and evaluation of communication, regulatory/quality knowledge, and ability to work in a matrix environment.
• Assessment of fit for complaint management and health authority reporting responsibilities.