Regulatory Affairs Specialist

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Regulatory Affairs Specialist

Duties For This Position Include The Following:

  • Develop and execute U.S. and international regulatory strategies.
  • Develop and execute Partial Reimbursement Clinical Trial strategies.
  • Establish and maintain Bioheart’s relationship with regulatory agencies, including U.S., foreign and Bioheart’s selected Registrar/Notified Body.
  • Clearly define the regulatory requirements necessary for regulatory approval to commence clinical trials or to gain approval for commercialization, help shape clincial protocols and submit final reports to regulatory agencies. Work closely with VP of Clinical Affairs & Physician Relations in all of these duties.
  • Ensure regulatory compliance with all applicable regulations with goal to gain full approval for commercialization in as many markets as possible as supported by the clinical data and filings. This includes gaining the regulatory approvals necessary to enter partial reimbursement clinical registry trials OUS.
  • Ensure compliance of Bioheart’s Quality System to all applicable ISO 9001/EN 46001, FDA Quality System Regulation cGMP requirements and any other applicable biologics regulations.
  • Support the efforts of Bioheart’s Biologics Division and Clinical Department as required.
  • Ensure safety of all patients treated with our products and assist with all regulatory filings in this regard.
  • Keep documents organized and ready for audit and ready for regulatory filings when required ie; an updated (general) foreign regulatory submission package should be ready to send upon request at all times.
  • Support team activities and assume responsibility for activities, as necessary, to fulfill company needs.
  • Ensure the quality, content and format of regulatory submissions.
  • Ensure consistency, completeness and adherence of standards for all submissions.
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