Abiomed a member of the Johnson & Johnson Family of Companies is currently recruiting for Senior Health Authority Reporting Clinician! This position will be located in Danvers, MA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Position Summary:
The purpose of the Customer Quality Clinician 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 may vary depending on the OpCo the individual is assigned to.
As applicable, Operating Companies will ensure they have adequate staffing including having individuals capable of providing Medical Judgement in relation to reportability determinations
Key Responsibilities:
- Demonstrate world class customer support and maintain knowledge of relevant OpCo’s products and services
- Provide Clinician Subject Matter Expert (SME) support and training across all OpCos. Provide project support where needed.
- Document clinical conclusions regarding the reportability assessment in the complaint record; utilize MD Workflow reports to identify tasks and manage common Email inboxes as applicable
- Determine device “Relatedness” to event (complex cases)
- Interface with MSOs
- Participate/Lead in Adverse Event (AE) Reviews
- Participate/Lead in the Reportability Matrices process
o Participate/Lead in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities
- Represents clinical interests in multi-disciplinary teams during product development
- Act as Point of Contact for questions & device patient safety escalations
- Assess specific complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include the review of selected codes product experience and patient codes for accuracy as well as maintaining and improving established coding guidelines to ensure consistency and accuracy with coding and reporting events.
- Make regulatory reporting determinations on applicable files for one or more Business Units and being able to file relevant regulatory reports
- Execute file reviews and assess patient medical records, making and/or reassessing MDR and/or MDV decisions and managing complaint files and maintenance of reportable malfunction lists and associated documentation.
o Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process
- Manage Standard and non-Standard Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with FDA and EU regulations as applicable
- Lead support for regulatory additional information requests and actively supporting compliance audits
- Lead/Actively participate in audit and compliance review processes
- Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures
- Participate/Lead in assigned projects towards desired business outcomes
- Participate/Lead the onboarding training of new associates and/or existing associates learning a new product as applicable
- Partner with and influence with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
