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Regulatory Affairs Associate I

Round Lk Bch, IL 60073

Posted: 01/31/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 542631 Is job remote?: No Country: United States

Job Description

Target Pay: 27-31/hr
Position Summary:

Under general supervision responsible for activities related to Certificates and Legalization in support of regulatory submissions and monitoring and maintenance of Device Establishment and Listing activities for US. Monitoring of regulations, guidance and standards associated with these activities. Maintenance of trackers. Special projects as assigned.

Major Duties and Responsibilities:

Certificates and Legalization:
  • Monitor regulations and maintain a clear understanding of various certificate processes
  • Effectively communicate with requestors to ensure that they fully understand what is needed/possible
  • Request certificates through proper channels whether directly from government agencies, or through other support functions
  • Work with legalization service to appropriately communicate requirements and ensure that proper legalizations are carried out
  • Maintain applicable trackers
  • Monitor, track and QC incoming certificates before ensuring that they are sent to the requestor

Device Establishment Registration / Listing:
  • Responsible for monitoring regulations and maintaining a clear understanding of FDA regulations
  • Assist in ensuring that Food and Drug Administrations (FDA) Unified Registration and Listing (FURLS) account is maintained appropriately
  • Assist with registration of device facilities and device listings within required timelines

Additional Responsibilities:
  • Assist with generation of user fee cover sheets, monitoring of budgets and payment of invoices, where needed
  • Obtain and maintain notary stamp in support of registration activities
  • Establish and maintain positive relationships with team and cross-functional counterparts
  • Identify, manage, and support Global Regulatory Affairs process improvements
  • Support additional projects as assigned

Requirements/Qualifications: Education: Bachelors degree Experience/Qualifications:
  • Knowledge of regulations
  • Administrative and project management skills
  • Ability to contribute to multiple projects from a Regulatory Affairs perspective
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Technical system skills in basic Microsoft office, tracking spreadsheets
  • Quick learner of new systems
  • Strong attention to detail (QC, proofreading)
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