Senior Regulatory Affairs Specialist
3 weeks ago
Job Description
Job 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.
Company Description 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.
Company Description
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.
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