Health Authority Reporting Analyst (Contract)

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 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.