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!
- 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
- 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!
Benefits
Vacation/PTO
Medical
Dental
Vision
401k
Bonus
Relocation
Telecommute
Applicants must be authorized to work in the U.S.
Matt Lynch is recruiting for this position and the positions below.
Email me to apply for this position
Employees will receive paid leave to the extent required by state or local law
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, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.
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.