International Regulatory Affairs Manager - Minneapolis, MN or 100% Remote

Inspire Medical Systems has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient's outcome is first and foremost our top priority. If you want to become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!

Position Summary:

We are recruiting for an International Regulatory Affairs Manager to join our team located in the Minneapolis, MN location. Reporting directly into the Vice President of Regulatory Affairs, you will be responsible for establishing strategy and supporting execution of global regulatory activities to obtain and maintain regulatory approvals in countries outside the United States, with a particular focus on Asia Pacific geographies. You will be collaborating with various functions within the organization including, but not limited to Research, Development, Quality, Clinical, and Operations, as well as regional partners (e.g., distributors, local sponsors/agents, and consultants).

Responsibilities:

• Provides direction, and leadership to meet schedules and resolve complex problems.
• Develops global regulatory strategies for Inspire products to meet business objectives and collaborates across a matrixed organization to ensure global availability of products.
• Participates on Product Development teams, provides international regulatory strategies, timelines, and direction.
• Negotiates with regulatory authorities to resolve questions/issues that arise.
• Participates in product change assessments and defines regulatory impact of product changes in global markets.
• Reviews and approves labeling, training, and promotional material.
• Maintains Regulatory Affairs product files and ensures compliance with regulatory requirements.
• Supports post-market activities.

Required Qualifications:

• Bachelor's Degree in Engineering, Sciences, or related discipline
• 10+ years of progressive medical device experience in regulatory affairs , including experience reviewing technical documents, interpreting new and changing international regulatory requirements, communicating impact to stakeholders, and/or supporting the development of implementation plans
• Previous experience obtaining and maintaining regulatory approvals in Asia Pacific geographies
• Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership

Preferred Qualifications:

• Advanced level degree Engineering, Sciences, or related discipline
• Demonstrated understanding of the regulations and standards relevant to Japan, Singapore, Hong Kong, and South Korea.
• Experience interacting with regulatory agencies.
• Experience addressing Radio Regulatory issues internationally.
• Proven ability to prioritize, conduct, and manage time to meet project deadlines.
• Demonstrated ability to work well in dynamic and cross functional team environments.
• Solid understanding of manufacturing and change control.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep dot com.

Inspire Medical Systems participates in E-Verify.