Medical Device Regulatory Affairs Specialist

San Diego, CA

Industry: Med Job Number: 123900
Medical Device Regulatory Affairs Specialist


Our client is a large producer of class two and three medical devices.  They are in need of a  Regulatory Affairs Specialist  who will be preparing Assurance Cases and 510K submissions. 

Principle Duties and Responsibilities:

The consultant will be a Regulatory Affairs Specialist from the medical device industry. They will be tasked with preparing/dealing with Assurance Cases for 510K submissions, dealing directly with Hazard Analysis Files . They must have experience with both Assurance Cases and 510K submissions to be qualified for the role. Ideally this consultant has a background with Infusion pumps and has dealt with submissions related to those types of devices. They must be able to work independently, as well as with a team of other consultants to get a submission done.


- Assurance Cases

-   5-7 years Regulatory Affairs

- 5-7 years Medical Devices

- 510(k) Submissions experience

- Infusion Pumps experience


- ASCE software experience (will be using to complete assurance cases)

Job Type: Contract

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