Vice President of Regulatory Affairs

A new client of Real Staffing is seeking a Vice President of Regulatory Affairs to join their growing organization. Our client is on the forefront of life changing technologies for individuals suffering from severe neurological disabilities. Here your role will be to help guide and collaborate with fellow industry leaders of Engineering, Clinical, and Quality as you develop and gain market approvals for novel technologies. You will be able to grow you personalize regulatory team, have a seat at the table for business decisions and make a lasting impact on standardization of care for this new age of medical devices. This is a once in a life time opportunity to be apart of boom market and organization poised to improve the life of those who have no other option.

Successful candidates will have the following:

• Experienced operating in executive Regulatory Affairs position
• Proven expertise and successfully gained approvals for 510k, PMA, IDE and De Novo submissions
• Tenured experience working within SaMD, Implant, and Ai/ML based technologies
• Strong working knowledge of both RA/QA and Clinical trials
• Willingness to be hands on technical and able to pivot as needed
• Previous experience negotiating and collaborating with FDA for novel technologies in Software, Ai/ML based products

Apply now for immediate consideration to be apart of a organization poised to change the industry in neurological care.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.