Adverse Events, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Documentation, FDA (Food and Drug Administration), HIPAA (Health Insurance Portability and Accountability Act), Healthcare, Medical Equipment, Presentation/Verbal Skills, Regulations, Regulatory Reports, Research & Development (R&D), SAP, Surveillance, Team Player, Writing Skills
**Contract-Role**
Must Have:
- 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
- Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths
- Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams
- Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping
- Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms.
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field
- Pay Range_ $25-$30/hr.
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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
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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