New · posted Nov 11
Inspire Medical Systems · Medical Devices
Sr. Regulatory Affairs Specialist
- Minneapolis, MN
- On-site
- Full-time
- Senior & Principal
What you need
Educational Requirements
- Bachelor's degree in engineering, life sciences, or related scientific discipline (or equivalent experience)
Required 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.
Preferred Experiencenice to have
- 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 Parts 11, 820, and 814
- EU MDR (EU) 2017/745
- ISO 13485 and ISO 14971
- IEC 60601, IEC 62304, and IEC 62366
- ISO 10993
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.
Salary
$110,000—$150,000 USD
What you'll do
MAIN DUTIES/RESPONSIBILITIES
- 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, and 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.
Pay and benefits
$110,000 – $150,000 a year
Employer providedWHY JOIN OUR FAST-GROWING TEAM
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.
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!
The Senior Regulatory Affairs Specialist will lead and execute regulatory strategy for an implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role supports global regulatory activities with primary focus on the United States and European Union.
Working independently under the direction of Regulatory Affairs Management, this position owns regulatory impact assessments and develops compliant, risk-based regulatory strategies across product development and lifecycle activities. The role requires strong collaboration with cross-functional partners and combines regulatory expertise, scientific knowledge, and business acumen to ensure products are developed, manufactured, and maintained in compliance with applicable global regulatory requirements. Experience supporting software-enabled or software-driven medical devices is strongly preferred.
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
Where you'll work
Minneapolis, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Minneapolis, MN
From the posting
About Inspire
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.
Equal opportunity, accessibility and legal noticesInspire Medical Systems's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $150,000 |
| All US (middle half) | $112,250 | $137,500 | $151,250 |
This role: Inspire Medical Systems's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 173 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Inspire's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Documentation and SOPs6
- Quality systems and risk5
- Collaboration and leadership5
- GMP and compliance3
- Data and digital systems2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Affairs work in medical devices, led by the 12 this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devicesNamed in the posting
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissionsNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipmentNamed in the posting
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devicesNamed in the posting
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management processNamed in the posting
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
Company hiring pulse
Inspire on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Regulatory1 33%
- Quality1 33%
- Clinical1 33%
By level
- Senior & Principal2 67%
- Manager1 33%
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Sr. Regulatory Affairs Specialist at Inspire
Open until filled. $110K–$150K a year, employer provided.