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Hybrid Principal Regulatory Affairs Specialist en Procept biorobotics

Procept biorobotics · San Jose, CA, Estados Unidos De América · Hybrid

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Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You:   
The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics (“company”) from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and  providing regulatory guidance to project teams.
 
The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs.
 
The ideal candidate would have had previous medical device experience and looking for potential for growth.
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