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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)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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