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Position summary
Biosense Webster is recruiting for Senior Health Authority Reporting Clinician.
Remote North America candidates will be considered for this position.
At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.
Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.
Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.
The purpose of the Senior Health Authority 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 outstanding customer support! This position will provide Clinician Subject Matter Expert support and training across Operating Companies. Provide project support where needed. The key focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.
Key Responsibilities
- Perform clinical conclusions regarding the reportability assessment in the complaint record
- Collaborate with Medical Safety Officers
- Lead Adverse Event reviews and the Reportability Matrices process
- Act as Point of Contact for questions & device patient safety escalations
- Assess specific complaint files within scope of internally and externally manufactured products in conformity with associated procedures
- Review and evaluate complaint files and patient medical records for reassessment of Medical Device Report and/or Medical Device Vigilance
- Appropriately use risk management documentation to improve the complaint’s regulatory reporting process
- Lead Health Authority Requests including justifications for non-reporting per the FDA and EU regulations as applicable
- Influence both internal and external teams by partnering with them to drive the vital changes of complaint related matters
What are Johnson & Johnson perks and benefits
Child care benefits
Paid maternity
Unpaid maternity
Paid paternity
Unpaid paternity
Paid adoptive
Short term disability
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