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Regulatory Affairs Specialist

Panama City, FL

Company Description

iSirona, based in Panama City Florida, boasts a new state of the art high tech corporate office and is among the fastest  growing Healthcare Information Technology organizations in the United States.  iSirona provides solutions to hospitals and ambulatory clinics for medical device data strategy.   The focus is on developing advanced technology that supports enhancements to workflow for clinicians and care providers.  Currently, iSirona is 120 plus clients strong and adding on an almost weekly basis. 

Job Description

Qualifications:

  • Ability to interpret regulatory requirements for product introductions
  • Ability to forecast regulatory submission schedules
  • Ability to partner with Product Management and Development to facilitate product introductions
  • Ability to develop Class I and Class II 510k Submissions; preferably for software medical devices and medical device data  systems
  • Ability to properly classify software medical devices in accordance with regulatory classifications
  • Ability to interpret new regulations and develop relevant procedures for implementation
  • Ability to prepare and deliver presentations focused on FDA regulations
  • Ability to initiate and close CAPA’s and Continuous Improvement Reports
  • Ability to interface with the FDA and other regulatory agencies to address and close any open issues concerning proper pre-market requirements
  • Ability to facilitate closure for  Medical Device Reportables and Class I (Critical) Complaints
  • Ability to complete certification procedures and documentation for establishment and product registrations

Qualifications

Skills/Education

  • At least 3 to 7 years of experience working as a Regulatory Specialist; preferably in a software medical device environment
  • Experience developing documents, presentations, spreadsheets, forms and templates using the entire Microsoft Office Suite
  • Familiarity with the ISO Software Lifecycle process is a plus
  • Must have experience with the application of Class I and Class II Pre-Market requirements
  • Must have experience interfacing and communicating with the FDA
  • Experience with international regulatory agencies is a plus
  • Experience with Trackwise and/or  SharePoint is a plus
  • Experience developing documents, presentations, spreadsheets, forms and templates using the entire Microsoft Office Suite
  • Must possess good communication skills
  • Must have experience with the application of the FDA’s Quality Systems Regulations and ISO quality regulations; especially design control requirements
  • Experience with SharePoint and/or Trackwise is a plus
  • Bachelor’s Degree or Equivalent in a Scientific Discipline

Additional Information

This position does require a nursing degree, and relocation to work out of the corporate offices in Panama City, FL.