Medical Device Regulatory Strategy and Pre-Submissions Bioabsorbable Implants SME

Boston, MA

Industry: Med Job Number: 122586

Medical Device Regulatory Strategy and Pre-Submissions Bioabsorbable Implants SME

Project Description:

The client is currently in need of a Regulatory Affairs subject matter expert to assist with Regulatory Strategy and Pre-Submissions with the FDA. They are seeking someone with a background in Non-active implantable devices and Bioabsorbable implants. They currently do not have a strong sense of knowledge in those two areas and will need assistance before preparing to submit to the FDA. The client has one product in their tool kit now and are looking to add a new one.

 Day to Day Responsibilities:

This consultant will be responsible for helping the Regulatory team prepare for pre-submissions for a bioabsorbable implantable medical device. They will be expected to counsel the team on Regulatory Strategy and how to successfully communicate with the FDA.

Required Skills:

- Medical Devices

- Regulatory Affairs

-Regulatory Strategy background

- Background assisting with pre-submissions to FDA

- Non-active implantable devices

-Bioabsorbable implants

Plus

-Surgical Mesh

- Permanent Implants

-Women' s Health

Job Type: Contract 

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