Post Market Complaint Specialist
Date de publication :
25 septembre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Johnson
Johnson & Johnson is currently seeking a Post Market Complaint Specialist to join our Abiomed team 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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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 position 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 complex complaint issues per department policies and guidelines.
- May prepare and/or reviews regulatory submissions and completes international vigilance reports of adverse events as required.
- Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.
- Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.
There is an internal pre-identified candidate for consideration. However, all applications will still be reviewed.
Contact
Synthes GmbH