Health Authority Reporting Contractor

Vita Global Sciences, a Kelly Company; West Chester (Chester County); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Full benefits

Paid time off

Job summary

Kelly Science and Clinical FSP seeks a Health Authority Reporting Specialist in West Chester, PA to review product complaints and support FDA/EU regulatory reporting. You will handle Health Authority requests, maintain complaint systems, and collaborate with cross-functional teams to ensure compliance.

The role requires 2–4 years of relevant experience, solid regulatory knowledge, and strong communication skills in English. Full benefits, PTO, and a long-term engagement are provided.

Qualifications

• 2–4 years of related experience desirable (combination of experience and education allowed).
• Regulatory knowledge: FDA, Medical Device Directives/Regulation, ISO requirements.
• Technical knowledge: anatomy, medical terminology, and applicable product unit knowledge.
• Education: completed apprenticeship or bachelor’s degree in scientific/health fields.

Responsibilities

• Review and process product complaints per internal and external procedures.
• Regulatory reporting determinations for FDA and EU requirements.
• Manage Health Authority requests and support audits and information requests.
• Coordinate investigations and forward follow-up questions as needed.
• Collaborate with internal/external stakeholders to drive corrective actions.
• Maintain familiarity with quality policies and participate in projects.

Skills

Communication

Decision-Making

Environment & Collaboration

Execution & Agility

Analytical

Education

Bachelor's degree or equivalent (Science/Health/Engineering)

Tools

MS Windows

MS Office

Collaboration tools

Job description

Kelly Science and Clinical FSP is currently seeking a Health Authority and Reporting Analyst for a long-term engagement in West Chester, PA with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

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.

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.

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.

Posted By: Lea Lolley