Job Summary
A health technology company is searching for a person to fill their position for a Remote Regulatory Affairs Specialist.
Must be able to:
- Support development of technical packages for Class II or Class III medical devices
- Write regulatory submission such as 510(k)s and PMAs and Technical Documents
- Maintain existing approved devices with post market change assessments
Skills and Requirements Include:
- US work authorization is a precondition of employment
- 2-3 years of medical device experience with BS degree, and work experience in regulatory affairs
- At least 1 year of medical device experience with MS degree, and work experience in regulatory affairs
- Must have a working knowledge of FDA, ISO, QSR, and EU regulations
- Knowledge of PC hardware/software, documentation, and archives
- Excellent oral and written communication skills
