Director, Regulatory Affairs

WHO WE ARE:

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.
Our lead therapeutics are in the following indications:

    • Spinal Fusion
    • Long Bone Repair
    • Osteochondral Repair
    • Dental and Facial Bone Repair

We are an innovative, fast-paced team that is advancing a diverse array of cutting edge translational research projects. With Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process first hand. Transform your career and join the Theradaptive team today!

POSITION SUMMARY:

We seek a talented Director of Regulatory Affairs to be part of our growing team. This person will have primary responsibility for overseeing regulatory matters and developing strategies to ensure compliance with regulations related to medical devices. They will provide regulatory guidance to project teams regarding design controls, product development, evaluation, and marketing.

The ideal candidate will have experience with PMA preparation, IND/NDA preparation, and IND module preparation and submission requirements. They will also have experience with combination products and associated rules for RFDs, having processed at least one combination product. The Director of Regulatory Affairs will also have expertise in device and drug cGMP, and regulatory work in more than one country.

 

If you are driven to contribute in an exciting and dynamic environment, we encourage you to apply now!