- 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
- 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
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 email@example.com. Candidates selected for interviews will be notified by phone or email.
iSirona - 16 months ago
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