Regulatory Specialist Ii

List 3-5 hard requirements for the role:

o Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.

o US Medical device and software regulations background, NO Pharma only Medical Device.

o Strong verbal and written communications with ability to effectively communicate with cross functional teams in the organization.

• List any preferred requirements that would stand out on a resume:

o Digital health technologies. o US medical device regulations.

o Software as Medical Device, 510(k) submissions.

o Experience with EU and other international medical device regulations and submissions, regulatory assessments.

• List Top 3 Skills you are looking for:

o Digital health technologies.

o Software/ medical device regulations, regulatory assessments.

• Years’ of experience required: 3+ years in Regulatory Affairs in medical device industry

• Required education level/certifications: Degree in science, engineering, or medical fields. • Daily tasks/duties and department interactions: Performing regulatory assessments, clear communication on requirements & regulatory questions/ responses with stakeholders, regulatory due diligence, documentation & record keeping.

Job Type: Contract

Pay: $58.00 - $62.00 per hour

Schedule:

• 8 hour shift

Work Location: In person