Regulatory Specialist

Contract: Alameda , California, US

Salary: $58.00 Per Hour

Job Code: 356982

End Date: 2025-01-17

Days Left: 25 days, 15 hours left

 Daily tasks/duties and department interactions:

  • Performing regulatory assessments, clear communication on requirements & regulatory questions/ responses with stakeholders, regulatory due diligence, documentation & record keeping.
  • Will be supporting impact assessments with both internal and external software partners.
  • Will also connect with 3rd party vendor apps that need to partner with devices and the regulations needed.

List 3-5 hard requirements:

  • 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.

Preferred requirements:

  • 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.

Top Skills:

  • Digital health technologies.
  • Software/ medical device regulations, regulatory assessments.

Required:

  • 3+ years in Regulatory Affairs in medical device industry
  • Degree in science, engineering, or medical fields.

Pay range:

  • $55-58/Hr
Job Requirement
  • Regulatory Affairs
  • medical device
  • Digital health technologies
  • 510(k) submissions
  • EU
  • mobile medical labs software
  • USFDA
  • OUS
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Sanjay Rawat
  • sanjay.rawat@collabera.com
  • 6305079880
Apply Now
Apply Now
close-icon

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.

Consultant Login
About
Resources
Phones Email

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.

Consultant Login

©2024 Collabera. All rights reserved.