Post Market Surveillance Specialist

Job Description

Job Description

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.

Our focus on patient outcomes is at the core of everything we do, and our think I can attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

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 hybrid work schedules, 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!

ABOUT THIS POSITION

This position will work in a team environment with members of Quality focusing on post market surveillance reporting requirements.

This position will specialize in documenting, evaluating, dispositioning and investigating product reports and identifying complaints as well as managing communications with Inspire field personnel.

This individual will also work closely with operations, engineering, sales, marketing and clinical to maintain product report files in accordance with Inspire policies, procedures and other medical device regulations.

The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Document and evaluate new product reports in accordance with required timelines for escalation, risk, coding and complaint designation.
• Facilitate product return process, disposition products and ensure return date and disposition status are documented.
• Lead product report and patient follow-up activities and document the results.
• Lead investigations as assigned and provide returned product kits to field personnel.
• Establish and maintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering.
• Communicate effectively with Inspire field personnel to ensure complaints are handled efficiently and effectively.
• Ensure regulatory and compliance requirements related to the complaint system process are fulfilled.
• Run basic complaint handling reports from the product reporting system.
• Compile data for regulatory reports as needed.
• Compose written communications to physicians regarding return receipt and other end use customers as directed.
• Train various team members on complaint handling process and system.
• This role requires computer and telephone-based work for extended periods of time in an office environment.
• This role may require shifts starting at 6 : 00am CST or ending at 8 : 00pm CST.
• This role may require coverage on occasional Inspire company holidays.

Required Qualifications

• High school diploma
• Minimum 2 years’ experience in a regulated industry or in a complaint or customer service role
• Proficiency with computer programs including, but not limited to : MS Office (Excel, Word, Outlook, etc)

Preferred Qualifications

• Bachelor’s degree
• Prior experience with complaint or regulatory handling
• Prior experience in an FDA regulated industry or ISO certified environment
• Experience in medical device or healthcare industry
• Experience with medical terminology

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, 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.

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