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Senior Regulatory Affairs Specialist (Remote)

Collabera Santa Clara, CA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Years' Experience:

· Must have 3-5 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 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, including directing development of 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, including EU MDR.

· Identify opportunity for regulatory affair processes and drive changes to completion. "

Company Description
Not only is Collabera committed to meeting and exceeding our customer’s needs, but we also are committed to our employees’ satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. We offer an enriching experience that promotes career growth and lifelong learning for our employees. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as one of the “Best Staffing Firms to Work For” since 2012 – eight consecutive years in a row. Collabera has 60 offices with a presence in 11 countries and provides staff augmentation, managed services and direct placement services to Fortune 500 corporations across the globe.

Collabera

Why Work Here?
Collabera works with some of the most progressive clients in the industry. This is an awesome opportunity to get your foot in the door!

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Santa Clara, CA
USA

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