What are the responsibilities and job description for the Regulatory Specialist position at Collabera?
Daily tasks/duties and department interactions:
- Performing regulatory assessments, clear communication on requirements & regulatory questions/ responses with stakeholders, regulatory due diligence, documentation & record keeping.
- Will be supporting impact assessments with both internal and external software partners.
- Will also connect with 3rd party vendor apps that need to partner with devices and the regulations needed.
List 3-5 hard requirements:
- 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.
Preferred requirements:
- 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.
Top Skills:
- Digital health technologies.
- Software/ medical device regulations, regulatory assessments.
Required:
- 3 years in Regulatory Affairs in medical device industry
- Degree in science, engineering, or medical fields.
Pay range:
- $55-58/Hr
Salary : $55 - $58
