Post Market Specialist II

Job Function

Quality

Customer/Commercial Quality

Professional

Danvers, Massachusetts, United States of America

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. The Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess 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.

• Analyze and process complaints in a uniform and timely manner, ensuring proper complaint coding and accurate complaint assessment.
• Complete assessments of product complaints to determine reportability and coordinate complaint investigations between the quality assurance department, engineering, customer support and other departments.
• 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.
• Perform data entry and prepare reports/graphs related to special projects, complaints and lot qualification as necessary.
• Complete Reportability Assessments in a timely manner in adherence with Abiomed’s policies and procedures.
• Identify possible trends related to complaints and present information or concerns to management using available programs and applications (PowerPoint, Excel, graphs, charts).
• Escalate complex complaint issues per department policies and guidelines.
• Work closely with engineering investigation teams to ensure the timely closure of technical investigations.
• Interact with cross‑functional teams to obtain information pertinent to the complaint investigation.
• Write customer letters.

• 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 (e.g., 21
  
  CFR 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., Trackwise, Salesforce).
• Possess strong complaint handling experience (e.g., 21
  
  CFR 820.198).

• Audit Management
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail‑Oriented
• Goal Attainment
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment

$79,000.00 - $

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program.

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hours for employees residing in Colorado; 56 hours for employees residing in Washington)
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480…