Complaint Management Associate I

GROW WITH US:

In Tandem means together, and we strive to embody that in every aspect of our business. Whether youre office-based or fully remote, Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and the healthcare providers supporting them through a positively different experience.

INNOVATE EVERYDAY

At Tandem, we strive to put our values into action. Our Team Up, No shortcuts approach has propelled us to be an industry leader and make significant strides in the diabetes technology space. We are proud to be the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Watch our latest video to see our product features and capabilities here:t:slim X2 Insulin Pump with Control-IQ Technology

A DAY IN THE LIFE:

The Complaints Management Associate supports Complaint Management Specialists during the product complaint submission process by drafting Medical Device Reports (MDRs). This role works closely with and is in constant communication with the Complaint Management Specialists they support in order to ensure MDRs are submitted correctly and in a timely manner.

YOURE AWESOME AT:



PRIMARY DUTIES & RESPONSIBILITIES:


Reviews assigned product complaint records and drafts MDRs that are submitted to the FDA as part of the overall complaint management process required for medical device products.

Effectively supports complaint handling process to ensure timely completion of complaint and MDR activities.

Supports Complaint Management Specialists in the drafting and filing of Medical Device Reports to ensure timely submission of adverse event reporting to FDA.

Uses and maintains database(s) and/or logs to track complaint and MDR activities.

Assists with the closure of complaints.

Assists with processing of complaint records under the supervision of Complaint Management Specialist.

Participates and supports departmental and quality system audits.

Assists in the training of new Complaint Management Associates.

Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

Other responsibilities as assigned.


REQUIRED QUALIFICATIONS:

Knowledge, skills & abilities:


Basic knowledge of ISO, FDA and cGMP concepts and guidelines preferred.

Familiar with the QSR and ISO13485 requirements preferred.

Basic knowledge of medical devices, their development and quality control.

Able to effectively share information related to work product in verbal and written form.

Demonstrated ability to work accurately, follow instructions and schedules, and handle multiple priorities.

Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Outlook.

Excellent written communication skills with the ability to write business and technical documents with minimal supervision.

Able to manage assignments with flexibility and adaptability in accordance with project priorities and by altering course of action when and where necessary.

Strong attention to detail.

Demonstrated experience working in a fast-paced, high-volume environment.


Minimum certifications/educational level:


Bachelors degree in relevant field preferred or equivalent combination of education and applicable job experience.


Minimum experience:


2 years administrative support experience

Medical device or biomedical field experience preferred.


WHATS IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit (link removed)

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we dont meet 100% of a job descriptions criteria maybe youre feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

REFERRALS:

We love a good referral! If you know someone that would be a great fit for this position, please share!



If you are applying for this job and live in California, please read Tandems CCPA Notice:

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