Job Description

If you are a Sr Regulatory Affairs Specialist with strong medical device experience looking for a 100% Remote role you must read on!

Headquarters in beautiful Pompano Beach, FL (a stone's throw from the white sand & green water!) 

We are an innovative and first-of-it's-kind Medical Device Manufacturer with the first FDA approved non-toxic pain management system that offers a critical alternative to the Opioid crisis! Our device is implanted into the patient thru a minimally invasive procedure, and then they can control the amount of pain relief they receive thru their smart device - it's that simple. Do you want to help people get access to this product asap? 

Candidate must be strong electrical and other engineering product standard experience helping put together EU MDR submissions and strong experience reviewing /creating product labeling, marketing materials, product claims, indications for use Maintenance of international licenses and registrations (MDSAP, Europe, Costa Rica, etc)!

What You Will Be Doing

• maintain licenses/registrations in existing territories
• support submissions for new international territories
• working within MDSAP, Europe, Costa Rica regulatory bodies
• reviewing product labeling, impact assessments of updates to standards/regulations
• Developing Regulatory Clinical Affairs
• Overseeing Regulatory Affairs Rule Interpretation Compliance, FMEA
• Spearheading MDRs / Vigilance Reports / Full Reg Clinical Affair Trajectory

What You Need for this Position

• 6+ years of professional OUS EUMDR Regulatory Affairs experience
• Experience with IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design
• BS in Engineering related field
• Experience with Medical Device Reg Affairs for implantable devices
• Working knowledge of 21 CFR 820, ISO 13485
• Strong experience with MDD, EU MDR, and MDSAP, Europe, Costa Rica etc

Benefits

• Huge Room for Growth!
• Bonus Opportunity
• Regular Company Functions
• Vacation/PTO
• Full Benefits: Medical, Dental, Vision
• Amazing Work Environment
• HUGE room for growth (lucrative startup)
• A team of sharp people on the same mission
• Must be authorized to work in the US without Sponsorship
• 401(k) with matching

Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Chad Vasquez

Applicants must be authorized to work in the U.S.

Preferred Skills

FDA

FDA Compliance

Medical Compliance

Australia

OUS

Canada

Biomed

Medical Device

Brazil

Regulatory Affairs

Job Tags

Full time, Relief, Immediate start, Remote job,

Similar Jobs