Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
The Sr Post Market Complaint Specialist is responsible for reviewing clinical and product complaints for patient safety events, adverse events, serious adverse events to assess for reportability in compliance with global medical device regulations. They are responsible for activities associated with clinical investigations for device and medical product related complaints and adverse events. The candidate must have experience in post-market regulations and requirements for medical devices and medical products, with a solid understanding of complaint handling investigations and adverse event follow up.
Principle Duties and Responsibilities:
Review all assigned clinical and product complaints for medical device 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 with full adherence to Abiomed's policies and procedures outlining complaint handling functions
Integrate relevant clinical information into the clinical case narrative to ensure a consistent database record for reports and queries
Prepare and submit medical device and drug reports according to global regulatory requirements, Abiomed's policies and procedures
Identify possible trends related to clinical complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint, Excel, BIRST, Minitab, graphs, charts)
Recognize when issues or trends occur and escalate to management as the situations arise
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
Perform periodic literature and online database searches per Abiomed's processes and to identify current industry trends, risks, harms, and hazards
Works closely with engineering investigation teams to assure the timely closure of technical investigations.
Interacts with cross-functional teams to obtain information pertinent to the complaint investigation.
Writes customer letters.
Job Requirements:
Minimum 5+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry
Bachelor's degree with5 years related work experience; Medical device experience preferred
Demonstrated knowledge of global medical device and/or pharmacovigilance regulations
Experience with FDA and international device/drug reporting requirements (experience with PMDA highly preferred)
Excellent written, verbal & interpersonal communication skills
Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word
Approachable, positive attitude and willing leadership abilities for mentoring for others as required
Critical thinker with meticulous decision-making capability
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
Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803, CMDR, Meddev 2.12, etc.)
Excellent verbal and written communication skills
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.