Senior Regulatory Affairs Specialist- #26-26662

US Tech Solutions, Inc.

  • Santa Clara, CA
  • 2 days ago
  • $66 Per Hour

Highlights

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. US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Numbers & Facts

LocationSanta Clara, CA
Salary$66 Per Hour

Description

Duration: 12 months
Job Description:
  • Exempt/Non Exempt: Non Exempt
  • Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Responsibilities:
  • 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 landscape, including EU MDR.
  • Identify opportunity for regulatory affair processes and drive changes to completion.
Experience:
  • Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Skillsets:
  • 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
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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