Job Summary
A medical technology company is filling a position for a Virtual Staff Healthcare Regulatory Affairs Specialist.
Individual must be able to fulfill the following responsibilities:
- Provide strategic input and technical guidance on regulatory requirements
- Assist in the development and update of regulatory strategy and SOPs
- Provide regulatory input for new product development and product lifecycle planning
Applicants must meet the following qualifications:
- Travel Percentage: 20%
- Bachelor’s degree in Engineering, Science, Regulatory or equivalent focus
- 5 years professional experience with at least 3 years direct regulatory affairs experience
- General understanding of product development process and design control
- Thorough understanding of FDA and international medical device regulations
- Ability to analyze and resolve non-routine regulatory issues using independent judgement