Medical Device Regulatory Affairs Project Manager

San Diego, CA

Industry: Med Job Number: 123898

Medical Device Regulatory Affairs Project Manager

Project Description:

Our client is a large producer of class two and three medical devices.  They are in need of a motivated and experienced project manager to manage a team of multiple Regulatory Affairs Specialists who will be preparing Assurance Cases and 510K submissions. 

 Day to Day Responsibilities:

This will be an individual with extensive project management experience. The  consultant will  be tasked with managing a team of multiple Regulatory Affairs specialists and  pushing their deliverables in regards to Assurance Cases and 510K submissions. Ultimately they will work to create an enterprise level Design History File. This person will need to work diligently with other members of the team, keep a detailed project schedule, report into senior management with progress updates, prepare presentations and facilitate the collaboration of multiple branches of the organization.

Having experience with Assurance cases and Regulatory Submissions in the Medical Device industry is a requirement.

Required Skills:

- Medical Devices

- Regulatory background (FDA)

- MS Project experience

- Assurance Cases



- Infusion Pumps

- Experience with ASCE software

- Design History Files

Job Type: Contract

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