Regulatory Affairs Manager

Looking for an experienced Regulatory Affairs Manager with Medical Device experience!

This Jobot Job is hosted by Emmet Nitto

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $110,000 - $155,000 per year

A Bit About Us

Based in San Jose, CA, we are a medical technology company developing minimally-invasive medical devices for lung diseases! We are looking for a Regulatory Affairs Manager to join our growing team!



Why join us?

• Competitive Salary!
• Extremely Competitive Benefits Package!
• The Opportunity to Join an Amazing Team!
• Bonus Incentives!
  

Job Details

• BS or MS degree required. Course program(s) or advanced training in Regulatory Affairs preferred
• Minimum 5 years experience in the medical device industry with 3 years in regulatory affairs role
• Previous FDA and OUS submission experience
• Ability to manage multiple priorities in a high-pressure environment
• Working knowledge of current revisions of
• EN ISO 13485 Medical Devices - Quality Management System
• MDD 93/42/EEC Medical Devices Directive
• MDR EU 2017/745 Medical Devices Regulation
• Support country registrations in EU Maintain current approvals, obtain approval in targeted countries
  

Interested in hearing more? Easy Apply now by clicking the "Apply" button.