Regulatory Affairs Project Leader

4 weeks ago

Santa Clara, United States Collabera Full time
Job DescriptionJob Description

·         Education: Bachelor's degree required, Master’s degree preferred

·         Experience: Minimum of 3 years of Regulatory Affairs experience

·         Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or device submissions.

·         Hands-on experience with 510k submission, or PMA/s or US Annual report or CE Technical Documentation preparation.

·         Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.

·         Communicates issues to management through project management tracking and issue briefings.

·         Position is highly visible to internal and external stakeholders.

·         High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict. Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry is strongly preferred, but not required.

·         Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.

·         Ability to manage and track broad and strategic projects.

·         Ability to communicate effectively in writing crisp briefings and issue analysis.

·         Demonstrated ability to work effectively in a team environment.

·         Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label material activities.

·         Responsible for effective communication of regulatory requirements to project teams and internal customers.

 

Additional Notes:

·         Must have RA submission experience. and EU & MU submissions experience

·         good writing and communication skills - Word, Excel

·         Bachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairs

 

Day to day:

·         Registrations - will train to do this up to 200 pages of documentation formatting

·         Complete technical documents for different Countries and submit to government agencies as well as the US.

 

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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