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Regulatory Affairs Professional
2 months ago
Collabera seeks a highly skilled Regulatory Affairs Specialist to support the development, implementation, and maintenance of regulatory affairs processes.
- Must have 1-3 years of experience in Medical Device Regulatory Affairs.
- Skills: Working knowledge in EU MDR, Regulatory Change Assessment, and US and EU medical device submissions.
- Experience supporting internal and external inspections.
- Ability to work cross-functionally and in a matrixed environment.
- Experience with continuous improvement activities.
- Education: BA/BS Degree.
Key Responsibilities:
- Assist in developing, updating, and improving regulatory affair processes.
- Support strategy implementation and operations for regulatory affairs activities, product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
Company Overview:
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI.
