Regulatory Affairs Specialist Job at CyberCoders, Laguna Hills, CA

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  • CyberCoders
  • Laguna Hills, CA

Job Description

If you are a Regulatory Affairs professional with a track record in Medical Devices, please read on! 

Job Title: Regulatory Specialist
Location: Laguna Hills, CA
Salary: $90-120k
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!

Benefits

Vacation/PTO

Medical

Dental

Vision

401k

Bonus

Relocation

Telecommute

Applicants must be authorized to work in the U.S.

Preferred Skills

Regulatory Affairs

FDA Guidelines

Medical Device directives (93/42/EC)

ISO 13485

Job Tags

Full time, Remote job, Relocation,

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