CyberCoders Regulatory Affairs Specialist - Medical Device in Lompoc, California
Regulatory Affairs Specialist - Medical Device Regulatory Affairs Specialist - Medical Device - Skills Required - Regulatory Submissions, Canadian & EU Medical Device requirements, ISO 13485, 510(K) Submissions
If you are a Regulatory Affairs Specialist with Medical Device experience, please read on!
---We are prepared to offer relocation assistance for the right candidate.---
We are a global industry leader with innovative breakthroughs in the science of cosmetic dentistry. We employ approximately 400 people around the United States and our company owns or has exclusive licenses covering more than 100 patents.
What You Will Be Doing
Prepare regulatory / 510(k) submissions
Review and approve product labeling
Provide regulatory input on inspection follow-ups and audits
Maintain FDA certificate to Foreign Government
Conduct regulatory assessments for changed to products
What You Need for this Position
Four year degree in a scientific field
3+ years Regulatory experience within the Medical Device industry
Canadian & EU regulatory knowledge / experience
ISO 13485 knowledge
Experience in FDA regulations
So, if you are a Regulatory Affairs Specialist with Medical Device experience, please apply today!
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.
Regulatory Affairs Specialist - Medical Device CA-Lompoc PD2-1446592