Job Summary
A manufacturer and seller of device-based medical therapies is filling a position for a Remote Cardiac Ablation Solutions Senior Regulatory Affairs Specialist.
Core Responsibilities Include:
- Preparing FDA and MDR/MDD submissions for products and product changes
- Providing support to currently-marketed products as necessary
- Reviewing only significant submission decisions/content issues with manager
Skills and Requirements Include:
- Bachelor’s degree and a minimum 4 years of experience in medical device regulatory affairs, quality, or engineering
- A minimum 2 years of experience in medical device regulatory affairs, quality, or engineering with an advanced degree
- Ability to provide feedback and on-going support to product development teams for regulatory issues and questions
