Regulatory Affairs Specialist
CyberCoders

Job Info

Regulatory Affairs Specialist If you are a Regulatory Affairs professional with a track record in pharma, biotech and/or medical device, please read on!


* Job Title:* Regulatory Affairs Specialist
* Location:* Laguna Hills, CA
* Salary:* $75-110k
*Requirements:* Regulatory Affairs work in either Med Device, Pharma or Life Sciences



This would be an amazing opportunity for you if you are looking a role that will provide professional growth and new challenges yet balanced with great culture and quality of life!
What You Will Be Doing -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
-Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies
-Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process
-This position will report directly to the VP, Quality and Regulatory Affairs
-Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs
What You Need for this Position 1+ years of experience with the following:
- IDE
- 510K
- PMA
- ISO13485
So, if you are a Regulatory Affairs Specialist with experience, please 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.