Regulatory Affairs Specialist in Alameda, CA

Position is 6 months from start date with possible extensions.

Position is 100% ONSITE ONLY in Alameda CA.

Manager is looking for:

List 3-5 hard requirements for the role:

• Experience in Regulatory submissions to USFDA and OUS Regulatory Authorities.
• US Medical device and software regulations background, NO Pharma only Medical Device.
• Strong verbal and written communications with ability to effectively communicate with cross functional teams in the organization.
• Solid medical device background especially on software US FDA or digital health regulations.

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

• Digital health technologies.
• US medical device regulations.
• Software as Medical Device, 510(k) submissions.
• Experience with EU and other international medical device regulations and submissions, regulatory assessments.
• Worked on mobile medical labs software.

 List Top 3 Skills you are looking for:

• Digital health technologies.
• 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.

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