Post Market Complaint Specialist (1 of 5)

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

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

Johnson & Johnson is seeking a Post Market Complaint Specialist (1 of 5) to be located in Danvers, MA.

This role is part of Abiomed’s Post Market Surveillance program inclusive of Regulatory reporting.

Our Regulatory reporting program is designed to meet FDA’s Quality system Regulation (QSR/Good Manufacturing Practices(GMP) and globally harmonized standard ISO13485 as well as any global regulatory standards based on product geography.

Based on the information received, determine if events meet appropriate regulatory requirements for adverse event reporting.

Generate appropriate regulatory reports based on assessment, communicate with business partners globally, and respond to regulatory authority requests.

This person will be instrumental in meeting Post Market Surveillance obligations.

There will be interdepartmental interactions involving Quality Assurance Engineering, Compliance, Technical Support, Customer Service, Commercial Operations and Regulatory Affairs.

The positions performs evaluations, review and submission of regulatory documents, preparation for audits and some communications with customers.

There will be opportunities to showcase talent, improve, develop and continuously foster growth.

Key Responsibilities:


* Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.


* Completes assessments of product complaints to determine report ability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments.


* Support investigations and review of potential adverse events.


* Perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary.


* Process feedback letters and communications with various reporting sites.


* Support investigations and review of potential adverse events.


* Escalate c...