Post Market Complaint Specialist
Not Disclosed•Full-TimeOn-site
location_on545, Hanover Avenue, Locustwood, Cherry Hill Township, Camden County, New Jersey, 08002, United States
About Johnson & Johnson
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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. We respect the diversity and dignity of our employees and recognize their merit.
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.
About the Role
We are searching for the best talent for the Post Market Complaint Specialist II position. This role is critical to ensuring the safety and efficacy of our medical devices by reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. You will serve as a bridge between quality assurance, engineering, customer support, and other departments, coordinating investigations and ensuring that root causes are documented prior to complaint closure. The position involves managing the operational aspects of the team, including workflow, performance, and compliance, while supervising individual contributors and assigning daily work. You will analyze complaints in a uniform and timely manner, prepare regulatory submissions, and escalate complex issues according to department policies, ensuring that our commitment to patient safety remains paramount.
Work location
Work model: On-site
545, Hanover Avenue, Locustwood, Cherry Hill Township, Camden County, New Jersey, 08002, United States
Cherry Hill Township, New Jersey
Key Responsibilities
- check_circleReview clinical and product complaints to assess reportability in compliance with global regulations
- check_circleSupervise individual contributors and conduct effective performance management
- check_circleAnalyze and process complaints to ensure proper coding and accurate assessment
- check_circleComplete assessments of product complaints to determine reportability and coordinate investigations
- check_circleSupport investigations and review of potential adverse events
- check_circleProcess feedback letters and communications with various reporting sites
- check_circleEscalate complex complaint issues per department policies and guidelines
- check_circlePrepare and review regulatory submissions and international vigilance reports
- check_circleEvaluate technical information to ensure root cause is documented prior to complaint closure
- check_circlePartner with functional departments to achieve effective corrective action on severe problems
- check_circlePrepare reports and graphs related to complaints, special projects, and lot qualification
- check_circleCoordinate daily work assignments and workflow for the team
Requirements
- verifiedBachelor degree or equivalent
- verifiedMinimum 2+ years experience in data management, record keeping, and troubleshooting in Medical Device field
- verifiedMinimum 3+ years of work experience processing complaints within device and/or pharmaceutical/life-sciences industry
- verifiedDemonstrated knowledge of global medical device and/or pharmacovigilance regulations
- verifiedWorking knowledge of domestic and international regulatory reporting requirements (i.e. 21CFR 803, CMDR, Meddev 2.12)
- verifiedProficient in Microsoft Office programs (Excel, PowerPoint, Word)
- verifiedExperience using a global complaint handling database or quality management system (e.g. ECM, Salesforce)
- verifiedPossess strong complaint handling experience (i.e. 21CFR 820.198)
Nice to Have
Medical device experience. Experience with PMDA.
Benefits & Perks
check_circleVacation – 120 hours per calendar yearcheck_circleSick time – 40 hours per calendar year (varies by state)check_circleHoliday pay, including Floating Holidays – 13 days per calendar yearcheck_circleWork, Personal and Family Time – up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Similar Job Opportunities
Skills, education and keywords
Skills: Microsoft Office, Excel, Powerpoint, Word, Salesforce, 21CFR 803, CMDR, Meddev 2.12, Pmda, 21CFR 820.198.
Education: Bachelor's degree or equivalent combination of education and experience.
Frequently asked questions about Post Market Complaint Specialist at Johnson & Johnson
What does a Post Market Complaint Specialist at Johnson & Johnson do?expand_more
A Post Market Complaint Specialist at Johnson & Johnson is responsible for the following: Review clinical and product complaints to assess reportability in compliance with global regulations; Supervise individual contributors and conduct effective performance management; Analyze and process complaints to ensure proper coding and accurate assessment; and Complete assessments of product complaints to determine reportability and coordinate investigations.
What are the requirements for this Post Market Complaint Specialist role?expand_more
Johnson & Johnson is looking for candidates who meet the following requirements: Bachelor degree or equivalent; Minimum 2+ years experience in data management, record keeping, and troubleshooting in Medical Device field; Minimum 3+ years of work experience processing complaints within device and/or pharmaceutical/life-sciences industry; Demonstrated knowledge of global medical device and/or pharmacovigilance regulations; Working knowledge of domestic and international regulatory reporting requirements (i.e. 21CFR 803, CMDR, Meddev 2.12); and Proficient in Microsoft Office programs (Excel, PowerPoint, Word).
Where is the Post Market Complaint Specialist role at Johnson & Johnson located?expand_more
Post Market Complaint Specialist at Johnson & Johnson is based in 545, Hanover Avenue, Locustwood, Cherry Hill Township, Camden County, New Jersey, 08002, United States. This is a on-site role.
Is this Post Market Complaint Specialist job remote, hybrid, or on-site?expand_more
Johnson & Johnson has listed this Post Market Complaint Specialist role as on-site.
How much experience is required for this Post Market Complaint Specialist role?expand_more
Post Market Complaint Specialist at Johnson & Johnson typically requires 3+ years of relevant experience at the mid level level.
What skills do you need for the Post Market Complaint Specialist role at Johnson & Johnson?expand_more
Key skills for Post Market Complaint Specialist at Johnson & Johnson include Microsoft Office; Excel; Powerpoint; Word; Salesforce; 21CFR 803; CMDR; and Meddev 2.12.
What education is required for Post Market Complaint Specialist at Johnson & Johnson?expand_more
Educational requirements for this role: Bachelor's degree or equivalent combination of education and experience.
What category does the Post Market Complaint Specialist role belong to?expand_more
Post Market Complaint Specialist at Johnson & Johnson is part of the scientific & qa job category on Recrutus.
About Johnson & Johnson
JNJ Online Auction Service of Fremont LLC specializes in facilitating the acquisition and disposition of medical equipment and assets for healthcare providers. Based in New Brunswick, NJ, the service supports hospitals, clinics, and health systems by offering a streamlined platform for auctioning surplus, used, or obsolete equipment. This solution helps institutions optimize resource management while ensuring cost-effective access to essential medical tools. Operating within the Hospitals and Health Care industry, the service aligns with its parent company’s commitment to advancing healthcare innovation through practical, scalable support systems. By connecting buyers and sellers in the healthcare sector, JNJ Online Auction Service of Fremont LLC contributes to improving operational efficiency and sustainability in medical facilities. The company’s approach reflects a focus on reliability, transparency, and meeting the evolving needs of healthcare professionals.
Browse more roles: All Johnson & Johnson jobs, scientific & qa jobs on Recrutus.