Adverse Events, Biotech and Pharmaceutical, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, FDA (Food and Drug Administration), Medical Equipment, People Management, Regulations, Regulatory Reports, Surveillance
Title - Adverse Event Specialist
Location - Mundelein, IL, 60060
Duration - 06 Months
Pay Rate: $25.00 - $30.00/hr
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
Job Description:
- 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry
- Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198)
- Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A
- Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping
- Direct people management experience
- Experience supporting FDA inspections and CAPA activities
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Collabera
Since 1991, Collabera has been a leading provider of IT staffing solutions and services. We are known for providing the best staffing experience and taking great care of our clients and employees.
Our client-centric model provides focus, commitment and a dedicated team to help our clients achieve their business objectives. For consultants and employees, we offer an enriching experience that promotes career growth and lifelong learning.
The Collabera Way represents our fundamentals beliefs and is founded on the following building blocks:
10,000 employees or more
Staffing/Employment Agencies