Medical Affairs Jobs in Minneapolis.
All active Medical Affairs roles based in Minneapolis.
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Regulatory Post-Market and New Market Access Analyst
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
Job Description:
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 and evaluate market access requirements for new geographies in Asia and Latin America, e.g., India, Brazil, and others as required. Conduct regulatory assessments of design and manufacturing changes, e.g. engineering change orders and supplier change requests. Assist with manufacturing and design changes and new product development submissions, as well as conducting 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.
Job 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.
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
- 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.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
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 regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, 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 need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Ready to apply?
Apply to Inspire Medical Systems Inc.
Medical Affairs Intern
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
Position Summary:
We are seeking a Medical Affairs Intern to join our team and support key Medical Education initiatives. This role will assist with the coordination and execution of educational trainings, meetings, and communications for Residents, Fellows, and other Medical Education programs.
The ideal candidate enjoys project management, multitasking, and attention to detail, and is comfortable coordinating multiple workstreams to ensure timely and successful delivery of projects. This internship offers hands-on exposure to academic and medical education initiatives within a collaborative, fast‑paced environment.
This position requires an in-office presence four days per week. Candidates must be located in the Twin Cities area for the duration of the internship.
This is a great opportunity to work closely with the Director of Academic Development and the Director of Medical Education, gaining direct insight into Medical Affairs and academic program development.
Main Duties/Responsibilities:
- Project Management: Coordinate with the Academic Development Team & Sales organization regarding our Fellowship program which includes scheduling meetings, introductions, and other details.
- Project Management: Coordinate with Medical Education team regarding our Advanced Practice Provider (APP) Education Programs and other Medical Education programs that support the Inspire therapy.
- Coordinate and participate in Residents and Fellows video series for continued learning.
- Data Management: Update data in Microsoft Dynamics working externally with Academic Centers to do so.
Educational Requirements:
- Currently pursuing a four-year degree in Business, Marketing, Data Management, or a related field
Required Experience:
- Strong attention to detail and organizational skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strong communication skills, both verbal and written.
- Ability to work independently and collaboratively.
- Willingness to take initiative and seek solutions.
Preferred Experience:
- Experience with Microsoft Dynamics and Smartsheets
- Experience working with remote teams or field-based professionals.
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
- 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.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
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 regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, 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 need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Ready to apply?
Apply to Inspire Medical Systems Inc.
Senior Regulatory Affairs Specialist
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
- Serve as a strategic regulatory partner to product development, operations, quality, clinical, manufacturing, and marketing teams, providing clear guidance on regulatory requirements and risks.
- Independently assess regulatory impact for new product development and post-market product changes, including design, manufacturing, labeling, and supplier changes.
- Develop and communicate regulatory pathway options and recommendations aligned with business objectives and global regulatory expectations.
- Compile, prepare, review, and submit high-quality regulatory submissions in the U.S. for PMA, IDE, supplements, and amendments, and EU for MDR Class III Technical Documentation, design change, notified body responses.
- Collaborate with subject matter experts to prepare accurate, timely, and professional responses to regulatory authority questions.
- Review and approve product development, operations, labeling, clinical, and software documentation to ensure regulatory compliance and submission readiness.
- Maintain accurate regulatory files, submissions, and tracking systems across the product lifecycle.
- Manage multiple projects simultaneously, maintaining high attention to detail, accountability, and execution quality.
- Complete all required training and maintain competency for assigned responsibilities.
- Comply with applicable Quality System procedures and regulatory requirements.
- Identify opportunities for continuous improvement in regulatory processes, tools, and documentation practices.
- Bachelor’s degree in engineering, life sciences, or related scientific discipline (or equivalent experience)
- 5+ years of experience in a regulated industry with transferable skills to medical devices.
- Strong technical writing, communication, and stakeholder‐management skills.
- Demonstrated ability to work independently on regulatory assessments and submissions.
- Medical device industry experience, in regulatory affairs, quality, and/or engineering.
- Direct experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA supplements, Pre-submissions, EU Technical Documentation and NB interactions.
- Experience interacting directly with regulatory authorities. e.g., FDA, Notified Bodies, or Competent Authorities.
- Regulatory support experience in one or more of the following areas:
- Active implantable medical devices
- Software regulated as a medical device or software as part of a medical device
- Manufacturing or supplier changes
- Working knowledge of applicable regulations and standards:
- 21 CFR Part 11, 820, 814
- EU MDR (EU) 2017/745
- ISO 13485, ISO 14971
- IEC 60601, IEC 62304, IEC 62366
- ISO 10993
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
- 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.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
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 regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, 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 need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Ready to apply?
Apply to Inspire Medical Systems Inc.