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Regulatory Affairs Specialist II - Molecular LLC Cypress United States,  

DiaSorin (company)

Posted on : 07 May 2017

Project Description

Job Scope
Your Mission 
Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Supports applicable regulations including Local, State, Federal and/or International requirements.    

Main Responsibilities
 Your Contributions   
  • Provide direction on submission support, international registrations, and labeling to junior department members. 
  • Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.  
  • Prepare global regulatory applications, as well as internal regulatory file documentation.  
  • Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations. 
  • Communicate with regulatory agencies on pre-market submissions related activities under the direction of management.  
  • Document consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc. 
  • Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.     

  • Bachelor s Degree   
  • Specialization  Life Science or Engineering   

  • Three to five years of pre-market regulatory experience in the medical device industry or equivalent (education and work experience). 
  • Must have knowledge of U.S, Canadian, European and other International in vitro diagnostic regulations and standards.  
  • Should have experience working on project/product from concept to market introduction.  
  • Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles and regulatory trends.   
  • US-RAC required with less than five years medical device experience.  Preferred with greater than five years regulatory experience, but not required.     

Technical Competencies   
  • Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.  
  • Must demonstrate leadership skills in team setting. 
  • Should have experience in presentation and negotiation of technical issues with internal and external functions including health authorities.     

Must be detailed oriented.
  •  Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations.
  •  Requires ability to speak effectively before groups of customers or employees of organization.
  •  Requires the ability to organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms.
  •  Requires ability to understand and interpret regulatory requirements and technical standards.
  •  Must have the ability to write and organize complex reports and correspondence to regulatory agencies.
  •  Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations.
  •  Requires ability to edit and proof documents with detailed accuracy.
  •  Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
  •  Must have ability to calculate dilutions, titrations, and other laboratory methodologies.
  •  Must be skilled in basic algebra and geometry.    

Languages  Fluent spoken and written English   
Travel Availability  0%   
Relocation Availability  Domestic USA candidates only   

Training Required  
  • US-RAC required with less than five years medical device experience.  
  • Preferred with greater than five years regulatory experience, but not required.    

 We Offer You  As per local and Company requirements for our company


Cypress United States

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