Regulatory Specialist II

Contract: Alameda, California, US

Salary: $55.00 Per Hour

Job Code: 356978

End Date: 2025-01-17

Days Left: 25 days, 14 hours left

To discuss more about this job opportunity, please reach out to Himanshu Kumar Singh(LinkedIn URL - https://www.linkedin.com/in/himanshu-kumar-singh-57b782258/), email your updated resume at Email - himanshu.ksingh@collabera.com or give me a call at (425) 403-0902. Thank you!

Pay Range: $50 - $55/hour

Position Details:
Industry: Medical Device
Duration: 6 months, with a possible extension
 
Job Roles & Responsibilities: 
  • Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.
  • US Medical device and software regulations background, NO Pharma only Medical Device.
  • Strong verbal and written communications with ability to effectively communicate with cross functional teams in the organization.
  • Solid medical device background especially on software US FDA or digital health regulations.
  • Digital health technologies.
  • US medical device regulations.
  • Software as Medical Device, 510(k) submissions.
  • Experience with EU and other international medical device regulations and submissions, regulatory assessments.
  • Worked on mobile medical labs software.
  • Digital health technologies.
  • Software/ medical device regulations, regulatory assessments.
  • Years’ of experience required: 3+ years in Regulatory Affairs in medical device industry
  • Required education level/certifications: Degree in science, engineering, or medical fields.
  • Daily tasks/duties and department interactions: Performing regulatory assessments, clear communication on requirements & regulatory questions/ responses with stakeholders, regulatory due diligence, documentation & record keeping.
  • Preferred interview method (one step or two step/phone or video conference): Two Step, 1 Video conference w/Sai and 2nd Video conference w/another member of team.
Job Requirement
  • Submissions
  • Regulatory
  • Medical Device
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Himanshu Singh
  • himanshu.ksingh@collabera.com
Apply Now
Apply Now
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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