Health Authority Reporting Contractor

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

• Complaint Processing & Customer Support
• Regulatory & Vigilance Reporting
• Health Authority & Audit Management
• Investigation & Stakeholder Collaboration

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

• 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.