Job Summary
A clinical and scientific staffing company is filling a position for a Remote Senior Regulatory Affairs Specialist III.
Individual must be able to fulfill the following responsibilities:
- Assist with regulatory issues related to labeling and marketing ideas
- Prepare documents required in the Development Life Cycle
- Recommend strategies for most efficient and effective approvals of regulatory applications for the business
Must meet the following requirements for consideration:
- Bachelors degree in a technical / healthcare / business discipline or equivalent
- Minimum of 10+ years of experience in the medical device industry and technical environment
- Must have experience with successful preparation and submission of 510(k) or PMA
- Software as a Medical Device 510k submissions experience
- Demonstrated experience with FDA pre-submissions
- Strong understanding of clinical trial data needed for 510k submissions
