Post Market Complaint Specialist

Johnson & Johnson • Danvers, MA

2d • Onsite

About The Position

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. You will be responsible for operational aspects of the team including, workflow, performance and compliance. You will supervise individual contributors and conduct effective performance management. You will coordinate processes and assignment of daily work for the team. You will assist in the review of the use of systems to ensure document standards are maintained. You will assist with implementation of process changes and procedural updates. You will analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment. You will ensure close partnerships with upstream and downstream customers to identify risks and improvement opportunities. You will complete assessments of product complaints to determine reportability and coordinate complaint investigations between the quality assurance department, engineering, customer support and other departments. You will support investigations and review of potential adverse events. You will perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary. You will process feedback letters and communications with various reporting sites. You will support investigations and review of potential adverse events. You will escalate complex complaint issues per department policies and guidelines. You may prepare and/or review regulatory submissions and complete international vigilance reports of adverse events as required. You will evaluate and confirm information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure. You will partner with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.

Requirements

• 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.
• 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
• Approachability 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. ECM, Salesforce
• Possess strong complaint handling experience (i.e. 21CFR 820.198)

Responsibilities

• Responsible for operational aspects of the team including, workflow, performance and compliance
• Supervises individual contributors and conducts effective performance management
• Coordinates processes and Assignment of daily work for the team
• Assists in the review of the use of systems to ensure document standards are maintained
• Assists with implementation of process changes and procedural updates
• Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• Ensures close partnerships with upstream and downstream customers to identify risks and improvement opportunities.
• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level