Health Authority Reporting Analyst

Health Authority Reporting Specialist

JOB SUMMARY

• This job description covers the purpose, responsibilities, skill sets, and associated training & education required for the Health Authority Reporting Specialist.
• The purpose of the Health Authority Reporting Specialist is to review and process product complaints received through various communication modalities and contribute to the complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support.
• Focus Areas:
• Regulatory Reporting to 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
• Duties & Responsibilities may vary depending on the Operating Company the individual is assigned to.

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate procedures and guidelines, this position will:

Complaint Processing & Customer Support

• Demonstrate world-class customer support and maintain knowledge of relevant Operating Company’s products and services.
• Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include 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 on applicable files for one or more Business Units.
• Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint files activities.
• File Medwatch report forms within required timelines as applicable.
• File MDVs in accordance to EEA, Switzerland, Turkey, candidate countries, and other third countries guidelines within required timelines as applicable.
• Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process.
• Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable.

Health Authority & Audit Management

• Manage Standard Health Authority Requests, including justifications for non-reporting in accordance with FDA and EU regulations as applicable.
• 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 complaint file management.
• Partner and influence with 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 towards desired business outcomes.
• Participate in the onboarding training of new associates and/or existing associates learning a new product.
• Participate in escalation process as required.
• Be responsible for communicating business-related issues or opportunities to the next management level.
• Be responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

EXPERIENCE AND EDUCATION

• Education: Completed apprenticeship OR Baccalaureate degree (preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field) OR University/Bachelor’s Degree or equivalent experience.
• Experience: 2–4 years related experience is desirable (a combination of experience and education can be allowed).
• Regulatory Knowledge: Knowledge of applicable quality, FDA (Food & Drug Administration), Medical Device Directives/Regulation, and ISO (International Organization for Standardization) requirements.
• Technical Knowledge: Knowledge of human anatomy, medical terminology, and products of applicable Business Units.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS

Skill Set

• 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, time management, ability to handle multiple priorities/sudden changes in priorities, and ability to work in a stressful/fast-paced environment.
• Analytical: Analytical/problem-solving skills, ability to learn, continuous improvement focus, and strong attention to detail.

Computer Skills

• General: PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint).
• Tools: Collaboration tools such as Microsoft Teams, Skype, Zoom, etc.