Manager, Clinical and 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!

Theradaptive is honored to be recognized as one of Maryland’s Future 20 Start-up Companies, an elite group of innovative start-ups with the “potential to be the state’s next major business success story”.

https://commerce.maryland.gov/media/governor-hogan-announces-marylands-future-20-startup-companies

POSITION SUMMARY:

We are seeking a proactive, enthusiastic, and independent Manager, Clinical and Regulatory Affairs with expertise in regulatory filings and management of clinical trials. The Manager, Clinical and Regulatory Affairs’ primary responsibility will be the preparation of US FDA pre-submissions and submissions, IRB/Ethics filings and trial management. The individual may be based in the Maryland/DC Beltway area but we will consider remote work.  This position will interact with all parts of the organization including Research and Development, Analytical Development, Regulatory and Quality. Knowledge of combination devices is a plus.

 

Our ideal candidate will possess a breadth of knowledge and creativity and will be highly motivated. The candidate will be detail-oriented and have a proven ability to multi-task and pivot quickly based on project priorities. Excellent interpersonal skills and the ability to work well with internal and external staff at all levels is an important skill set needed to succeed in this role.

 

If you are driven to contribute in a highly dynamic environment, we encourage you to apply now!