Job description
Regulatory Affairs Manager
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.
If you are a Regulatory Affairs professional with a track record in Medical Devices, please read on!
Job Title: Regulatory Manager
Location: Laguna Hills, CA
Salary: $100-140k
Requirements: Regulatory Affairs, Management, FDA, Medical Device Directives (93/42/EC), ISO 13485
This would be an amazing opportunity for you if you are looking for a role that will provide professional growth and new challenges yet balanced with great culture and quality of life!
Job Title: Regulatory Manager
Location: Laguna Hills, CA
Salary: $100-140k
Requirements: Regulatory Affairs, Management, FDA, Medical Device Directives (93/42/EC), ISO 13485
This would be an amazing opportunity for you if you are looking for a role that will provide professional growth and new challenges yet balanced with great culture and quality of life!
What You Will Be Doing
- Oversee the process of obtaining FDA Approvals, CE Mark, and other foreign regulatory approvals.
- Handle regulatory submissions and registrations
- IDE, PMA, 510(k), Design Dossiers, Technical Files, and other regulatory filings.
- Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.
- Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
- Work interdepartmental with Engineering & R&D product development project teams
What You Need for this Position
- Successful track record in Regulatory Affairs
- Current knowledge of FDA Guidelines
- History of Medical Device directives (93/42/EC)
- Strong understanding of ISO 13485
We are actively interviewing so APPLY TODAY!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Matt Lynch
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.
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