POST MARKET COMPLAINT SPECIALIST

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.
nj.
om/.
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 ISO 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.
Qualifications Education.
Bachelor degree or equivalent combination of education and experience with a minimum of 2+ year’s experience with data management, record keeping, and trouble shooting in Medical Device field, or other transferrable experience related to organization, technical aptitude, and data management.
Experience and Skills.
Preferred.
Support investigations and review of potential adverse events.
Escalate complex complaint issues per department policies and guidelines.
Ability to communicate at multiple levels of an organization.
Ability to organize and judge priorities.
PC skill, word processing, spreadsheet, database Able to work effectively in a high-stress, high energy environment.
Able to make decisions quickly based on vague information and evaluate the need to obtain clarification and direction when necessary.
This position is a desk job and requires sitting for extended periods of time.
Required.
Maintain Abiomed’s Post Market Surveillance documentation per Abiomed procedures and Regulatory requirements to stand on its own in the event of an audit.
Comply with all regulatory requirements, company policies, operating procedures, processes and task assignments.
Preparation/review and Submission of documentation of reportable events to Regulatory Authorities within required timelines.
Support Competent Authority inquiries, Adverse Events and Serious Injury reporting and Risk Management worldwide.
Coordinate and maintain closure of complaint records within required timelines within our Post Market Surveillance system.
Support the review and evaluation of customer communications for complaint reporting obligations.
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 •• Other.
English language proficiency is a requirement.
10% both national and international.
Day shift Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.