Sobre este puesto de Manager, MDR & Vigilance en Inspire Medical Systems Inc.
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
The Manager, MDR & Vigilance is responsible for leading post-market surveillance and vigilance activities, including complaint evaluation, reportability assessments, regulatory reporting, team oversight, and process management. This role partners closely with Quality, Regulatory, Clinical, Medical Affairs, Reliability, and Operations to support timely and compliant reporting to regulatory authorities and strengthen the overall post-market surveillance program.
The role provides direct leadership for the MDR and Vigilance team, manages daily priorities and resources, supports team development, and ensures the function operates effectively, consistently, and in compliance with global reporting requirements.
MAIN DUTIES/RESPONSIBILITIES
- Lead the MDR and Vigilance team, including day-to-day direction, workload prioritization, coaching, performance feedback, and employee development.
- Set team expectations, monitor progress against reporting timelines, and address barriers that could impact compliance, quality, or turnaround time.
- Oversee evaluation and assessment of product complaints to determine global reportability requirements and ensure timely regulatory submissions.
- Manage day-to-day post-market surveillance operations and ensure compliance with FDA, EU MDR, and other applicable global vigilance regulations.
- Develop, maintain, and enhance vigilance procedures, work instructions, metrics, and compliance monitoring processes.
- Allocate resources and establish priorities to meet reporting timelines, departmental objectives, and regulatory requirements.
- Make decisions on workload balancing, issue escalation, and team support to keep daily vigilance activities moving effectively.
- Partner with Regulatory Affairs, Clinical, Reliability, Medical Affairs, and Quality teams to support investigations and regulatory reporting activities.
- Monitor reporting trends, identify compliance risks, and implement corrective actions and process improvements.
- Serve as the primary escalation point for complex complaint investigations, reportability assessments, and cross-functional alignment needs.
- Drive operational initiatives focused on process efficiency, quality improvements, automation, and reporting effectiveness.
- Prepare and communicate performance metrics, compliance updates, and recommendations to Quality leadership.
- Support regulatory inspections, audits, and responses to health authority inquiries related to vigilance activities.
- Manage external stakeholder communications and requests related to adverse event reporting and complaint investigations.
- Ensure team training, competency assessments, and compliance with Quality System requirements.
- Build team capability through training, coaching, clear guidance, and ongoing support in complaint evaluation, reportability assessments, and global reporting expectations.
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements.
QUALIFICATIONS
Educational Requirements: Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.
Required Experience: 7+ years of experience in medical device quality, complaint handling, MDR reporting, or vigilance activities.
Preferred Experience: Previous leadership, supervisory, or team lead experience preferred.
- Strong knowledge of FDA MDR, EU MDR Vigilance, and global adverse event reporting regulations.
- Experience managing cross-functional initiatives and operational processes.
- Strong analytical, communication, and organizational skills.
#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.
