Apply on Employer Site

Enterra Medical, Inc. · 3 weeks ago

Senior Principal Regulatory Affairs Specialist

St Louis Park, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$150K/yr - $180K/yr

10+ years exp

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, ensuring compliance with FDA and international standards.

Health CareManufacturingMedicalMedical Device

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

Qualification

Medical Device Regulatory AffairsRegulatory strategy developmentQuality management systemsFDA interactionEuropean Notified Bodies complianceOrganizational managementTechnical managementEffective communication

Required

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

Company

Enterra Medical, Inc.

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.* Gastroparesis is a condition in which food moves through the stomach too slowly, causing chronic nausea and vomiting.

Founded in 2022

Minneapolis, Minnesota, USA

51-200 employees