Regulatory Affairs Specialist (Eumdr) $90K Base (100% Remote)

If you have EUMDR Regulatory Affairs experience, we want to talk to you, please read on!
This role is 100% Remote
The best Medical Device industry titans are crushing it, yet again! With the first of it's kind non toxic pain management med device that is FDA approved, covered by insurance, and shipping across the globe! Don't wait, this opportunity to be part of Reg Affairs is one of the most critical parts of our org - it can be yours! Apply now.
Top Reasons to Work with Us

• 100% REMOTE
• Bleeding Edge Technology = smart device to control pain relief!

What You Will Be Doing

• Overseeing Regulatory Affairs Rule Interpretation Compliance, FMEA
• Maintain licenses/registrations in existing territories
• Developing Regulatory Clinical Affairs
• Review product labeling, impact assessments of updates to standards/regulations
• Support submissions for new international territories
• Spearheading MDRs / Vigilance Reports / Full Reg Clinical Affair Trajectory

What You Need for this Position

• BS in Engineering related field
• 3-5+ years of professional OUS EUMDR Regulatory Affairs experience
• Experience with Medical Device Reg Affairs for implantable
• Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP

What's In It for You

• HUGE room for growth (lucrative startup)!
• Amazing Work Environment!
• Regular Company Functions / Lunches / Stocked Kitchen!
• Competitive Base Pay (we will pay for the best!)
• A team of sharp people on the same mission!
• 100% REMOTE
• Full Benefits: Medical, Dental, Vision for employee and all dependents!
• Vacation/PTO!

Benefits

• Dental
• Bonus
• 401k
• Medical
• Vacation/PTO
• Vision

So, if you are a Regulatory Affairs Specialist with experience, please apply today!
Priority will be given to candidates who fill out the questionnaire, thank you!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Chad Vasquez
Email Your Resume In Word To
Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
[email protected]

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : CV6-1735025L628 -- in the email subject line for your application to be considered.***

Chad Vasquez - Lead Recruiter - CyberCoders
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.