Be an early applicantLess than 25 applicants

Company

iCAD · 3 hours ago

Regulatory Affairs Consultant (FDA)

United States

Contract

Remote

Mid Level

3+ years exp

Maximize your interview chances

Health CareHealth Diagnostics

H1B Sponsor Likely

Hiring Manager

Brian Testa

Insider Connection @iCAD

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Focus on new product FDA pre submission and submission work

Work with a cross-function team to prepare the documents for collection of both a pre-submission request for the subject device and a 510K submission for the subject device

Review previous presubs to ensure thorough history of device

Review FOIA package

Provide any insights for presub

Work cross functionally to create the subject device’s device description to be used for the pre-submission

Review and comment on protocol to be used to support device performance

Confirm applicable standards

Create draft questions

Work cross functionally to develop the PCCP

Work cross functionally to support label development

Work cross functionally to develop HFE protocol

Review FOIA for guidance on templates for required documents

Cross functional deliverables

Prepare for meeting

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

510K submissionOHT8 (radiology)PreSTARESTARCybersecurity requirementsSDLCHuman factors studiesCommunicator

Required

3-5 years of 510K submission work in radiology

2-3 successful 510K submissions for software devices

Working knowledge of cybersecurity requirements

Strong knowledge of SDLC (software development life cycle)

Strong communicator

Experience with human factors studies

Experience working with OHT8 (radiology) on software as a medical device

Experience using both preSTAR and eSTAR

Company

iCAD

iCAD is a medical technology that offers cancer detection and therapy solutions.

Founded in 1984

Nashua, New Hampshire, USA

51-200 employees

http://www.icadmed.com

H1B Sponsorship

iCAD has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (2)

2021 (2)