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 yearA 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!
- 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.