Experience:
No experience
Employment Type:
Full time
Posted:
6/14/2017
Job Category:
Engineering
Regulatory Affairs Specialist
Chart Industries | Ball Ground, Georgia
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Job Description

Ensuring Chart’s Success…

Chart Industries is a growing, global company with more than 5,000 employees and operations in Europe, Asia, Australia and the United States. We make high quality, highly engineered products that improve people’s lives, advance medical research and contribute to a cleaner, more sustainable world. The Chart Ball Ground Facility is currently looking for a Regulatory Specialist to join our expanding operations.

 

What Your Day-to-Day Activities Will Be…

  • Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, CMDCAS, etc.
  • Lead the initial effort to secure the required product approvals including document submissions to regulatory authorities and notified bodies.
  • Proactively maintain existing approvals including submission of renewal paperwork.
  • Work with Engineering on new product releases and changes to develop Regulatory Plans including required testing, approvals, labeling and post market reporting.
  • Work with Engineering to develop and maintain MDD and TPED technical files.
  • Lead efforts to develop processes to ensure continued regulatory compliance for products and processes.
  • Work with Design and Development Project teams to ensure compliance with Design Control Requirements.
  • Assist with training in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding regulatory requirements and reporting.

 

Your Professional Experience Should Be…

  • Experience and working knowledge with standards and test requirements associated with medical electrical equipment
  • Experience with various Codes and Standards (ISO 13485, FDA, QSR, MDD, TPED, CMDCAS, etc) is preferred.
  • Experience with U.S. FDA 510K submittals as well as international medical device approvals.
  • Working knowledge and experience with ISO 13485 Quality Systems practices
  • Good communication skills at all levels (written and verbal)
  • Proven ability to work with cross-functional teams and in a project management environment
  • Demonstrated ability to plan and manage multiple tasks/projects
  • BS degree.

 

Chart Industries is an Equal Employment Opportunity Employer.

About Chart Industries

Chart Industries, Inc. (Chart) is an independent manufacturer of engineered equipment used in the production, storage and end-use of hydrocarbon and industrial gases, based on its sales and the estimated sales of its competitors. The Company supplies engineered equipment used throughout the global liquid gas supply chain. The Company manufactures engineered equipment primarily used for low-temperature and cryogenic applications. The Company has also developed cryogenic systems and equipment. The Company's products include vacuum insulated containment vessels, heat exchangers, cold boxes and other cryogenic components, which are used throughout the liquid gas supply chain for the purification, liquefaction, distribution, storage and end-use of hydrocarbon and industrial gases. The Company operates in three segments: Energy & Chemicals, Distribution and Storage and BioMedical. (Source: 10-K)

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