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International Regulatory Affairs Specialist - United States  

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Posted on : 04 April 2017

Project Description

Description:
  • The International RA Specialist is responsible for developing strategies for moderately complex submissions to regulatory agencies worldwide.  
  • Interprets regulations and guidance’s ex-U.S. and communicates to the country how these impact the ability to register.  
  • Coordinates and supports worldwide product registration requests, interfaces with global international regulatory and marketing contacts to support regional registration requirements, and develops and maintains department procedures for international product registrations.
  •  Assembles technical information, in order to fill the registration requirements.
  •  In addition, the Specialist is responsible for understanding the needs of the regions and how to meet their registration needs as well as the objectives of the business.


Job Description
  • Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale and Certificates of Exportability.  Interfaces with applicable regulatory agencies and international consulates.
  • Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements.
  • Interfaces with OEM's to collect specific registration information.
  • Assembles technical information to create a "clinical report" or a "dossier".
  • Acts as lead for key countries, as identified, managing each request to completion.
  • Recognizes and proposes continuous process improvements.
  • Assists in the preparation of Technical Files for CE marking, checklists for Australia and for Singapore.
  • Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations.



Qualifications
  • BS or BA degree in a technical or scientific discipline or 5 years of cumulative work experienced in a Quality Assurance or Regulatory Affairs or other closely related field.
  • Prefer 3 to 5 years' related experience plus Bachelor's degree.
  • Concentration in clinical diagnostics preferred.  International registration experience preferred.
  • Demonstrates good technical/scientific skills on multiple product lines.
  • Knowledge of both US and worldwide registration and regulatory requirements. 
  • Ability to effectively communicate both verbally and in writing to all levels internally and externally.
  • Proficient in Microsoft Office Suite; with exceptional skills in constructing, populating and maintaining databases and spreadsheets.
  • Strong communication and project management skills.
  • Must be able to handle multiple tasks, prioritize and pay close attention to details.