Regulatory Compliance Coordinator - Tisch Cancer Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 
Roles & Responsibilities:

  • Provides regulatory support to clinical trial project teams.
  • Participates in the preparation of FDA 510(k), IDE, PMA, PMA supplement and submissions.
  • Prepares international regulatory submissions, CE Mark product dossiers and Technical Files/Design Dossiers. Ensures QA of submissions. 
  • Conducts reviews of labels, literature and Web site for accuracy, consistency and regulatory compliance.
  • Develops and/or revises regulatory policies and procedures. 
  • Prepares annual reports for PMA devices and drugs.
  • Performs other duties as assigned. 

 

 

Requirements:

  • Bachelor’s Degree preferably in the science of legal areas. 
  • A minimum of 3 years of direct experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the Medical Device Industry. 


Strength Through Diversity

The Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together.
 
We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care. 

Explore more about this opportunity and how you can help us write a new chapter in our story! 

Who We Are

Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
 
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
 
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation. 

EOE Minorities/Women/Disabled/Veterans

 

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