OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs, PMAs, and PMA supplements.
The role supports regulatory change assessments, keeps abreast of standards, and may involve domestic and international travel. A Bachelor's degree in engineering or life sciences is required.
#J-18808-LjbffrSenior Regulatory Affairs Specialist – SaMD/SiMD, Remote in madison at Unknown Company
This position is listed as full time and onsite.