Job Summary

A medical device manufacturing company needs applicants for an opening for a Remote Regulatory Affairs Bardy Diagnostics Manager.

Core Responsibilities Include:

• Supporting product development and sustaining engineering projects
• Preparing regulatory documentation and manage pre-market submissions to relevant authorities
• Developing/advising company on regulatory strategies for new medical device products

Position Requirements Include:

• Minimum of seven plus years of progressive experience in medical device regulatory affairs
• Bachelor’s degree or equivalent in technical discipline
• Strong working knowledge of US and international medical device regulations and standards
• Successful preparation and submission of 510(k)s and/or international documents and registrations
• Experience with developmental best practices for medical device hardware and software
• Strong oral and written communication and presentation skills