This job has been removed
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Fri, Aug 05, 2022
This job expires in: 20 days
Job Summary
A medical device manufacturing company is filling a position for a Remote Regulatory Affairs Bardy Diagnostics Manager.
Core Responsibilities Include:
- Supporting product development and sustaining engineering projects
- Developing/advising company on regulatory strategies for new medical device products
- Preparing regulatory documentation and manage pre-market submissions to relevant authorities
Must meet the following requirements for consideration:
- Minimum of seven plus years of progressive experience in medical device regulatory affairs
- Bachelor’s degree or equivalent
- Successful preparation and submission of 510(k)s and/or international documents and registrations
- Strong working knowledge of US and international medical device regulations and standards
- Experience with developmental best practices for medical device hardware and software
- Ability to work independently and as part of team, strong collaborative skills