Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. The candidate must have experience in medical device and post-market regulations with a solid understanding of complaint handling processes and adverse event follow up.

Principle Duties and Responsibilities:

• Review all assigned clinical and product complaints for adverse events
• Interface with field reps. and clinical staff to acknowledge, document and obtain detailed information regarding adverse events and incidents received by the company
• Apply knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events as they are received
• Complete Reportability Assessments in a timely manner in adherence with Abiomed’s policies and procedures
• Prepare and submit medical device adverse event reports according to global regulatory requirements and Abiomed’s policies and procedures
• Integrate relevant clinical information into the clinical case narrative to ensure a consistent database record for reports and queries
• Identify possible trends related to complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint, Excel, graphs, charts)
• Assist with writing Health Risk Assessments, presenting at patient safety meetings, compiling safety summaries for annual reports, and other input into safety reports as needed or requested
• Work closely with engineering investigation teams to assure the timely closure of technical investigations
• Interact with cross-functional teams to obtain information pertinent to the complaint investigation

Job Requirements:

• Minimum 3+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry
• Bachelor’s degree; Medical device experience preferred
• Demonstrated knowledge of global medical device and/or pharmacovigilance regulations
• Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803, CMDR, Meddev 2.12, etc.) (experience with PMDA highly preferred)
• Excellent written, verbal & interpersonal communication skills
• Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word
• Approachable with a positive attitude
• Critical thinker
• Exceptional attention to detail in documenting events, composing clinical narratives, and editing quality documents
• Demonstrated ability to manage multiple competing priorities and meet deadlines
• Ability to work independently and as a team player
• Experience using a global complaint handling database or quality management system e.g. SmartSolve (Pilgrim), Salesforce
• Possess strong complaint handling experience (i.e. 21CFR 820.198)

Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.