Regulatory Affairs Specialist Job at CyberCoders, Laguna Hills, CA

T2FWZWdTMTVlbVkyeEh1bU5OL1EzZEF4QWc9PQ==
  • 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,

Similar Jobs

Integrity Placement Group

Family Practice Physician Job at Integrity Placement Group

 ...Family Practice Physician Our growing medical center is looking for a full-time Family Practice Physician in Myrtle Beach SC. We strive to offer exceptional health services and deliver quality, compassionate care to everyone. We provide a wide range of affordable... 

PRC Resources

Bilingual Water Transfer Field Supervisor Job at PRC Resources

 ...INDUSTRY : Midstream Oilfield Services; Water Transfer LOCATION : 2 positions - West Texas (Midland/Odessa area) and New Mexico...  ...will oversee water transfer operations, ensuring compliance with safety standards, environmental regulations, and operational efficiency... 

Potawatomi Federal Solutions

Government Realty Specialist Job at Potawatomi Federal Solutions

 ...Position Title: Government Realty Specialist Division: Advancia Aeronautics, LLC Location: Remote FLSA Classification: Non-Exempt...  ...: Potawatomi Federal Solutions is a federal government contractor who provides essential services and administrative support to... 

TKO StaffPros

Reach Truck and Forklift Operators Job at TKO StaffPros

 ...Reach Truck & Sit-Down Forklift Operator Location: Wilmer, Texas Pay Rate: $22/hour Shift: 12-hour shifts (potentially rotating)...  ...Ability to lift up to 50 lbs frequently. - Capability to stand, sit, bend, and perform repetitive tasks throughout the shift... 

Hilton

Guest Service Agent - Hampton Inn & Suites Tampa Oldsmar Job at Hilton

 ...greeting and registering guests and checking guests out of the hotel in the hotel's continuing effort to deliver outstanding guest service...  ...What are we looking for? Since being founded in 1919, Hilton has been a leader in the hospitality industry. Today, Hilton remains...