Medical Device Safety Reviewer

Medical Device Safety ReviewerWe are seeking a dedicated Medical Device Safety Reviewer to collect, review, assess, and process complaints and reports related to medical device adverse events and device deficiencies in clinical studies. This role requires compliance with global regulations, including seriousness assessment, labeling, causality, and follow-up data received. The reviewer will perform medical assessments for post-market device portfolio cases and escalate as needed to the MDS physician. The ideal candidate will maintain an understanding of medical device/combination product risk management regulations and applicable standards and guidance documents. The position supports and participates in audits and inspections as needed.Responsibilities:Collect, review, assess, and process complaints and reports related to medical device adverse events and device deficiencies.Perform medical assessments for post-market device portfolio cases and escalate as needed.Maintain an understanding of medical device/combination product risk management regulations and applicable standards.Support and participate in audits and inspections as needed.Manage workload responsibilities primarily related to medical device safety management, including prioritizing workload, training, database reconciliation, and safety surveillance.Troubleshoot problems and escalate issues to the manager as necessary.Mentor and coach designated Medical Device Safety staff on assigned activities.Essential Skills:Expertise in Medical Device Reporting.Registered Nurse with active RN License in good standing (any state).4+ years of experience in post-market medical device safety/surveillance.Proficiency in complaint handling and processing.Experience with 21 CFR Part 803 and 21 CFR Part 806.Additional Skills & Qualifications:Bachelor of Science in Nursing (BSN).Experience with combination product quality assurance (QA).Familiarity with quality management systems (QMS) and FDA regulations.Work Environment:This position offers a 100% remote work environment with expected working hours aligned to Central Standard Time (CST).Job Type & Location:This is a Contract position based out of North Chicago, IL.Pay and Benefits:The pay range for this position is $45.00 - $50.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)About Actalent:Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.