Health Authority Reporting Analyst

About the Role

The Health Authority Reporting Specialist reviews and processes product complaints received through various communication channels, contributing to the complaint management system in line with internal and external procedures while providing world-class customer support.

Key focus areas include:

• Regulatory reporting to the FDA under 21 CFR, Part 803
• Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1
• Device-specific vigilance guidance and other relevant regulations
• Management of health authority requests

Responsibilities

Complaint Processing & Customer Support

• Demonstrate world-class customer support and maintain knowledge of relevant products and services
• Assess, process, and close complaint files for internally and externally manufactured products in accordance with complaint handling procedures and quality expectations, including assigning product experience and patient codes
• Utilize MD Workflow reports to identify tasks and manage common email inboxes

Regulatory & Vigilance Reporting

• Make regulatory reporting determinations for applicable files across one or more business units
• Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint file activities
• File MedWatch report forms within required timelines
• File MDVs in accordance with EEA, Switzerland, Turkey, candidate countries, and other third-country guidelines within required timelines
• Utilize risk management documentation to support the complaint’s regulatory reporting process
• Maintain the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities

Health Authority & Audit Management

• Manage standard health authority requests, including justifications for non-reporting in accordance with FDA and EU regulations
• Support regulatory additional information requests and actively support compliance audits
• Participate in audit and compliance review processes as needed

Investigation & Stakeholder Collaboration

• Create and/or forward additional information follow-up questions as part of complaint investigation
• Assign appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and file management
• Partner and influence stakeholders both internally and externally to drive needed change and/or execution of complaint-related matters

General & Operational Responsibilities

• Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures
• Participate in assigned projects toward desired business outcomes
• Participate in the onboarding training of new associates and/or existing associates learning a new product
• Participate in the escalation process as required
• Communicate business-related issues or opportunities to the next management level
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures
• Perform other duties as assigned

Requirements

Education

• Completed apprenticeship or
• Baccalaureate degree (preferably in a scientific, medical, life science, health science, technical, or engineering field) or
• University/Bachelor’s degree or equivalent experience

Experience & Knowledge

• 2–4 years of related experience is desirable (a combination of experience and education may be considered)
• Knowledge of applicable quality, FDA (Food & Drug Administration), Medical Device Directives/Regulation, and ISO (International Organization for Standardization) requirements
• Knowledge of human anatomy, medical terminology, and products of applicable business units

Skills & Abilities

• Communication: Strong written and verbal communication skills; fluent spoken/written English required
• Decision-Making: Strong decision-making skills—able to make sound business decisions with sometimes limited information
• Environment & Collaboration: Ability to work in a cross-functional and matrix environment; ability to work and interact with co-workers to accomplish company goals in a team environment
• Execution & Agility: Ability to work independently, manage time effectively, handle multiple priorities/sudden changes, and work in a stressful/fast-paced environment
• Analytical: Analytical/problem-solving skills, ability to learn, continuous improvement focus, and strong attention to detail

Technical Skills

• PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint)
• Familiarity with collaboration tools such as Microsoft Teams, Skype, Zoom, etc.

Benefits

Kelly offers eligible employees voluntary benefit plans, including:

• Medical, dental, vision, and telemedicine
• Term life, whole life, accident insurance, and critical illness
• A legal plan and short-term disability
• Access to a retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• A transit spending account
• Paid sick leave under applicable state or local plans