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Form of workJob Description
- Must have 1-3 years of experiences in Medical Device Regulatory Affairs
- Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions
- Have experience supporting internal and external inspections
- Work cross-functionally and in a matrixed environment
- Have experience with continuous improvement activities
- Education: BA/BS Degree
Required Duties:
- This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
- Assist the strategy implementation and operations for Regulatory Affairs activities, product registration submission, 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. Identify opportunity for regulatory affair processes and drive changes to completion.
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. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
