Health Authority Reporting Analyst

About this role

Job Title: Health Authority Reporting Analyst

Department: Medical Device

Location: Wes Cester, PA- 1301 Goshen Parkway, West Chester, PA 19380 (Hybrid 2 To 3 Days a week)

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 complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support. Focus areas are 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, other relevant regulations as appropriate and management of Health Authority Requests.

DUTIES & RESPONSIBILITIES

• 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.

• 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 and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable

• Create and/or forward additional information follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management.

• 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

• Manage Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable

• Supporting regulatory additional information requests and actively supporting compliance audits

• Participate in audit and compliance review processes as needed

• 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

• Partnering and influencing with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters

• Be responsible for communicating business related issues or opportunities to 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

• Completed apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor’s Degree or equivalent experience

• 2-4 Years related experience is desirable (A combination of experience and education can be allowed)

• Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements

• Knowledge of human anatomy, medical terminology and products of applicable Business Units

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Skills Set

• Strong written and verbal communication skills. Fluent spoken/written English required.

• Strong decision-making…