Senior Principal Regulatory Affairs Specialist

Enterra Medical, Inc.•Saint Louis Park, MN

8d•$150,000 - $180,000•Hybrid

About The Position

Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy. The Senior Principal Regulatory Affairs Specialist will be responsible for regulatory strategies and associated daily activities. The ideal candidate will have need to have a minimum of 10 years' experience in Medical Device Regulatory Affairs.

Requirements

10+ years of experience in Medical Device Regulatory Affairs required.
Organizational management, technical management, skilled at organizational procedure and policy making, successes leading teams, excellent understanding of technology and regulations.
A track record of implementation and management of quality management systems
Ability to communicate effectively, orally and in writing
Direct experience interacting with FDA on PMAs and PMA Supplements, European Notified Bodies on CE Marks, and other regulatory bodies in other regions of the world
Ability to travel to meet with customers, suppliers, and other stakeholders
A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and/or in vitro diagnostic medical devices.

Responsibilities

Responsible for the strategic direction, planning and management of Regulatory projects and activities for Enterra Medical products
Achieve regulatory deliverables within project timelines and milestones with relevant FDA, EU, ISO and other regulatory requirements and standards
Responsible for pre-market activities and post-market regulatory affairs activities
Support clinical evaluation approvals for various therapy needs domestically and internationally
Author and submit regulatory filings
Manages and maintain worldwide country registrations and regulatory databases for the FDA and Notified Bodies and other regulatory agencies
Ensure documents meet regulatory requirements for FDA, Notified Bodies, and other agencies
Report analysis of regulatory strategy and status to the company
Review and assesses marketing materials for compliance
Drive continuous improvement in Regulatory processes
Represent regulatory affairs in product development project teams
Define the requirements for regulatory submissions for international and domestic markets
Work with Operations team to assure regulatory compliance.
Other duties as assigned.