Regulatory Affairs Specialist
iSirona - Panama City, FL

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Job Description Qualifications:
  • Ability to interpret U.S. and international regulatory requirements for medical devices
  • Ability to develop Class I and Class II 510k Submissions; preferably for software medical devices
  • Ability to forecast regulatory submission schedules
  • Ability to partner with Product Management and Development to facilitate product introductions
  • 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 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 review labeling and marketing material for compliance with regulatory requirements
  • Experience with international filings and medical device classifications
  • Experience with the application of the FDAs Quality Systems Regulations and ISO quality regulations; especially design control requirements

Qualifications Skills/Education:
  • At least 3 to 7 years of experience working as a Regulatory Specialist; preferably in a software medical device environment
  • 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
  • Must possess good communication skills
  • Bachelors 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.

iSirona provides an exciting and rewarding career opportunity in a fast-paced atmosphere with full benefits and unlimited growth potential. Applicants that adapt to change, handle competing priorities, and communicate effectively will thrive in this environment.

iSirona is an EEO/AA employer.

If interested, please email your resume to careers@isirona.com. Candidates selected for interviews will be notified by phone or email.

iSirona - 16 months ago - save job - block
About this company
NANTHEALTH is a transformational healthcare company converging science and technology through an integrated clinical platform that’s...