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QA Specialist in Riverside, IL at APEX Systems

Date Posted: 1/11/2019

Job Snapshot

Job Description

Job #:  927135

Apex Systems is looking for a QA Specialist for a large Healthcare client in Greater Chicago!

8+ Month Contract Role

CANDIDATE MUST BE FLUENT IN SPANISH


Latin America Quality Regulatory Affairs Specialist Essential Duties and Responsibilities: 

  • Responsible for the coordination and support of Latin America product registration requests throughout the product life cycle
  • Support regional and country colleagues to develop and implement global regulatory strategies 
  • Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements 
  • Collaborate with regional regulatory personnel on assessing and documenting the regional impact of product changes on global product registrations and licenses. 
  • Knowledgeable in Latin American regulations and is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues
  • Demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships
  • Responsible for coordinating the submission of Technovigilance reports in the region

Skills/Qualifications: 

  • Must be fluent in Spanish
  • Minimum three years of experience in Regulatory Affairs, preferably with a global manufacturer of medical devices.
  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
  • Strong attention to detail with strong organizational and technical writing skills. Must have strong written and verbal communication skills
  • Must manage multiple projects simultaneously
  • Must have experience working on multidisciplinary teams in a fast-paced, dynamic environment

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178