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RN BSN/Adverse Events Specialist
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Actalent
Remote
$88,400 Salary, Full-Time
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Job Description
Job Title:
RN Adverse Events Specialist RN (BSN preferred) with Illinois license Must have recent/current experience ICU orER/ED NO
clinical research experience is necessary! This is a great way to branch out into the Device/Pharma industry!!! $40-45/hr Job Description The Adverse Events Specialist is tasked with managing product complaint remediation and processing new complaints for reportability. This role involves reviewing both historical and newly received complaints to determine Medical Device Reporting (MDR) reportability in accordance with current procedures and regulatory requirements. The specialist ensures all MDR submissions comply fully with FDA reporting requirements, 21 CFR 803, and Quality System regulations. Responsibilities Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees. Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision. Work cross-functionally with Quality, Regulatory Affairs, R D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments. Prepare and submit MDRs through the FDA's electronic submission portal (eMDR) for newly identified reportable events. Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations. Essential Skills Experience with 21 CFR 803 Knowledge of Medical Device Reporting Understanding of Adverse Event reporting Familiarity with FDA regulations Competency in Pharmacovigilance and Drug Safety Skills in Case Processing and Surveillance Expertise in Regulatory Affairs Experience in Pharmaceutical industry standards Understanding of GxP and GCP Work Environment The role offers a hybrid work environment, with on-site work required on Tuesdays and Thursdays in Mundelein, IL. This position involves collaboration with various departments and may require interactions with international regulatory contacts. The work setting is dynamic, supporting a leading provider of medical-surgical products and supply chain solutions. Job Type & Location This is a Contract to Hire position based out of Mundelein, IL. Pay and Benefits The pay range for this position is $35.00 - $40.00/hr. 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) Workplace Type This is a hybrid position in Mundelein,IL.