Senior Regulatory Affairs Specialist

2 months ago

Saint Paul, United States Collabera Full time
Job DescriptionJob Description

·         Perform assigned regulatory activities including submissions/responses to country authorities.

 

Daily Responsibilities - Job Description suppliers should use:

·         Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.

·         Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.

·         Assist in maintaining Regulatory records and files.

·         Review product changes as assigned and assess required EU MDR submissions/notifications.

 

Educational Requirements:

·         BA Degree required, preferably in a science, engineering or technology discipline.

·         Work Experience Requirements: 3-5 years experiences in Medical Device Regulatory Affairs Top

 

Skills:

·         Strong oral communication and interpersonal skills

·         Proficient in technical writing

·         Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.

·         MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and monitoring these/Conditional Formatting.

 

Company DescriptionCollabera 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 DescriptionCollabera 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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