Regulatory Affairs Specialist Job at CyberCoders, Laguna Hills, CA

  • 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!










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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