The right talent can transform your business—and we make that happen. At Collabera, we go beyond staffing to deliver strategic workforce solutions that drive growth, innovation, and agility. With deep industry expertise, a global talent network, and a people-first approach, we connect you with professionals who don’t just fit the role but elevate your business. Partner with us and build a workforce that powers success.
Senior Regulatory Affairs Specialist (Remote)
Contract: Minneapolis, Minnesota, US
Salary Range: 50.00 - 60.00 | Per Hour
Job Code: 330407
End Date: 2023-04-25
Job Status: Expired
This Job is no longer accepting applications
To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!
Job Description:
Job Roles & Responsibilities:
- Science related Bachelor’s Degree required
- 2+ years of regulatory experience in med device highly preferred
- Preferred local candidates – hybrid two a week, but open to remote
- Assist with transcatheter heart valve line
- Post market type activities and manufacturing operations
- Reviewing change requests
- Update product documents
- Determine regulatory changes for EEUS and other geographies
- Request changes to processes if required
- Assisting with suppliers or adding new suppliers
- Order requests for FDA post market reports
- Someone with manufacturing, change orders, regulatory experience – some submission writing experience a plus
- Writing submissions possible – month reports
Job Requirement
- Regulatory Affairs Specialist
- Regulatory Affairs
- FDA
- post market
- regulatory
- MDR
- EU MDR
- submission
- Medical Device
Reach Out to a Recruiter
- Recruiter
- Phone
- Chitrank Rastogi
- chitrank.rastogi@collabera.com
- 4255231648
This Job is no longer accepting applications
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