• Acts as Team Lead for specialty programs, medical review, utilization management, and case management areas. • Provides leadership/guidance/direction/training to staff. • Maintains a working knowledge of unit functions and the ability to interpret to new hires. • Acts as a resource for staff/external entities troubleshooting as well as resolving issues. • Keeps manager informed of any problems/issues that need resolving. • Assists management with monitoring workflow and workloads. • Participates in departmental quality reviews. • Gives/receives feedback regarding medical review decision making and technical claims processing issues. • Participates in compliance initiatives and other directed activities. • Participates/oversees special projects as requested by management.

• Performs medical reviews using clinical/medical information provided by physicians/providers and established criteria/protocol sets or clinical guidelines • Documents decisions using indicated protocol sets or clinical guidelines • Provides support and review of medical claims and utilization practices • Performs medical claim reviews for one or more of the following: claims for medically complex services, services that require preauthorization/predetermination, requests for appeal or reconsideration, referrals for potential fraud and/or abuse, and correct coding for claims/operations • Makes reasonable charge payment determinations based on clinical/medical information and established criteria/protocol sets or clinical guidelines • Determines medical necessity and appropriateness and/or reasonableness and necessity for coverage and reimbursement • Documents medical rationale to justify payment or denial of services and/or supplies • Educates internal/external staff regarding medical reviews, medical terminology, coverage determinations, coding procedures, etc. in accordance with contractor guidelines • Participates in quality control activities in support of the corporate and team-based objectives • Provides guidance, direction, and input as needed to LPN team members • Provides education to non-medical staff through discussions, team meetings, classroom participation and feedback • Assists with special projects and specialty duties/responsibilities as assigned by Management

Role Description 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. - Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment. - Completes assessments of product complaints to determine reportability and coordinates 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 (e.g. 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. Qualifications - 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. Trackwise, Salesforce. - Possess strong complaint handling experience (i.e. 21CFR 820.198). Requirements - 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. 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.

Role Description Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. - Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. - Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. - Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. - Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. - Perform aggregate and signal analysis activities, as required in support of single case processing. - Create, maintain, and assume accountability for a culture of high customer service. Qualifications - Bachelor’s degree in medical science or MD or DO or equivalent degree. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. - Language Skills: Speaking: English at ILR level 3+ or higher. - Writing / Reading: English at ILR level 4+ or higher. Requirements - Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. - Knowledge and understanding of regulatory requirements for Clinical Research. - Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include - 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment - Office or home-based environment, as requested by the line manager.