Regulatory Post-Market and New Market Access Analyst

Inspire Medical Systems • Minneapolis, MN

19h • Onsite

About The Position

Inspire Medical Systems is seeking a Regulatory Post-Market and New Market Access Analyst to provide regulatory support for their neurostimulation therapy for obstructive sleep apnea. This role will focus on US and international regulatory submissions and evaluating market access requirements for new geographies, particularly in Asia and Latin America. The analyst will also conduct regulatory assessments of design and manufacturing changes, assist with submissions for new product development, and perform gap assessments between existing documentation and new market requirements. A key part of this role involves direct interaction with regulatory agencies and reviewing labeling and promotional materials for compliance. The analyst will also be responsible for generating and approving various quality system documents.

Requirements

• Bachelor’s degree in engineering, pharmacy, or relevant scientific field.
• Five (5) years of progressive experience in Regulatory Affairs or a related discipline in the medical device industry.
• Two (2) years of experience specifically in Regulatory Affairs, which may have been gained as part of or in addition to the required progressive experience.
• Experience must include US Class III devices.
• Authoring a variety of regulatory submissions for US and EU related to implantable devices.
• Basic submission processing experience with submission portal use and fee processing systems.
• Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
• Must have current authorization to be employed in the U.S. without employer sponsorship.

Responsibilities

• Provide regulatory support for neurostimulation therapy for the treatment of obstructive sleep apnea in adult and pediatric patients.
• Focus on US and international regulatory submissions.
• Evaluate market access requirements for new geographies in Asia and Latin America.
• Conduct regulatory assessments of design and manufacturing changes, such as engineering change orders and supplier change requests.
• Assist with manufacturing and design changes and new product development submissions.
• Conduct gap assessments between Inspire’s US and EU regulatory documentation and the regulatory requirements in new geographies.
• Interact directly with regulatory agencies at the reviewer level.
• Review labeling and promotional material for regulatory compliance.
• Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Equity awards.
• Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees