ISIJP00011313 Sr Regulatory Affairs Specialist Avail for w2 ref

Req#ISIJP00011313

Sr Regulatory Affairs Specialist
Max pay rate - $105/hr W2
Sunnyvale, CA (3 Days Onsite) Remote option only for Super Strong Candidate.

Key requirements include a strong understanding of software, design controls, and the ability to write 510(k) submissions.

Looking for someone who carry understanding of medical devices and Regulatory Affairs.

Someone who has very strong experience with 510 Ks, who has written 510 Ks, who understands the three-sub process with FDA, those are the two big asks.

Third Important task: someone who is very strong with design controls, who understands the design control process, the expectations in terms of documentation and coverage. Also, someone who has a strong understanding of medical software side and DDS, class two software.

This role is primarily more focused for US FDA submission.

This person will be preparing its own submissions or technical documents.