Careers

Join our Talent Network

Share your email below and we will keep you posted on career opportunities.

Already a Member

Search Careers

Share this Job

Regulatory Specialist

Date: Jun 12, 2018

Location: Canton, GA, US, 30114

Apply now »
Apply now

Apply for Job

Ensuring Chart’s Success…

Key member of the BioMedical product team to ensure continued regulatory compliance for all products.  Works with Engineering and 3rd party test labs to ensure completion of product testing required for global approvals and license.  Coordinates the assimilation of documentation required for global product approvals/license including U.S. 510K’s, EU MDD certifications, Health Canada License, China FDA license, and other approvals as required.

 

 

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, TPED and PED technical files.
  • 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 and associated reporting requirements.

 

                                                                                       

Your Professional Experience Should Be…

  • Experience with various Codes and Standards (ISO 13485, FDA, QSR, MDD, CMDCAS, etc.) required.
  • Working knowledge of ISO 13485:2016 and MDSAP a plus.
  • Experience with U.S. FDA 510K submittals.
  • Experience and working knowledge with international product approvals.
  • 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

 

 

Your Education Should Be…

  

  • BS degree required, preferably an engineering or technical degree.

 

Your Physical Work Environment Will Require

 

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle or feel objects, tools or controls and talk or hear. The employee is occasionally required to stand, walk, stoop, kneel, crouch or crawl.

 

 

Chart Industries is an equal opportunity employer.

 


Nearest Major Market: Atlanta

Apply now »
Apply now

Apply for Job

Join our Talent Network

Share your email below and we will keep you posted on career opportunities.

Already a Member