I3 INFOTEK INC · 1 day ago
Regulatory Affairs Specialist
United States
Contract
Remote
Senior Level
5+ years exp
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Hiring Manager
Aman Kumar Snehi
Insider Connection @I3 INFOTEK INC
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Responsibilities
Are you an experienced Regulatory Affairs Specialist seeking a challenging opportunity? Our client in the medical device industry is looking for a Senior Regulatory Affairs Specialist with expertise in US submissions and FDA regulations. This is a remote role requiring availability to work in the Pacific Standard Time (PST) zone.
Qualification
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Required
Bachelor’s degree or higher.
At least 5+ years of experience in regulatory affairs within the medtech, pharmaceutical, or biotechnology industries.
Strong expertise in US submission requirements and FDA regulations.
Proven experience managing complex projects related to product development and registration processes.
Excellent verbal and written communication skills, enabling effective collaboration across departments.
Proficient in analyzing data sets with strict adherence to quality control guidelines.
Skilled in managing multiple time-sensitive deadlines while maintaining high work standards.
Company
I3 INFOTEK INC
i3infotek, an MSRcosmos group company is a Lifesciences, Medical devices, and healthcare consulting and professional services provider.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
