VS- Regulatory Affairs Specialist - Alameda, CA at Rangam Infotech Private Limited
Alameda, CA 94502
About the Job
“Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.”
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.