Job Title: Senior Regulatory Affairs Specialist

Location: Fully Remote (Memphis, Tennessee)

Duration: 18 Months (Possible extension)

Pay Rate: 40.00/HR on W2 (All Inclusive)

Note from Hiring Manager: Looking for EU MDR submission experience, Orthopedics and 510k experience.

Job Details:

• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices

• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.

• Manage/le...