Clinical Trials, Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
4 Year Degree
Zenflow is looking for a dynamic and experienced clinical and regulatory professional who can drive strategy and execution of our upcoming clinical trials and regulatory approval efforts.
BS/BA in relevant field
At least 10 years of experience in clinical and regulatory affairs in the medical device industry
Results driven, collaborative team player capable of working well with others
Willing to think differently, challenge industry norms, and adapt to rapidly changing startup company conditions
Strong verbal and medical writing communication skills
Able to be physically present in office at least 3 days per week
Experience planning and executing large, randomized clinical trials
Experience leading discussions and submissions in at least the US and Europe
Strong understanding of ISO 14155, ISO 13485, ISO 14971, 21 CFR 820, and other critical international standards
Willing to travel up to 20% of the time, including international travel
Medical device quality systems experience
At least 15 years of experience in clinical and regulatory affairs in the medical device industry
At least 5 years of experience in a director/senior director/VP-level role
Experience with urologic medical devices
Experience with implantable medical devices
Ability to be present in the office 5 days per week
Experience in a leadership role involving quality assurance
Employer will assist with relocation costs.
Additional Salary Information: Will pay competitive salary
Internal Number: 0001
Zenflow is a start-up medical device company based in South San Francisco, California. We have developed the Spring System, an implantable device placed in the prostatic urethra for the treatment of Lower Urinary Tract Symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH or enlarged prostate). This condition affects almost all men at some point in life. We designed the Spring System to deliver safe and effective longterm relief in a simple procedure performed in the doctor’s office.