Regulatory Specialist II
7 days ago
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.
- Preferred interview method (one step or two step/phone or video conference): Two Step, 1 Video conference w/Sai and 2nd Video conference w/another member of team.
Will be supporting impact assessments with both internal and external our software partners. - Will also connect with 3rd party vendor apps that need to partner with our devices and the regulations needed.
Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
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