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Product Reporting Specialist III at Medtronic in Northridge, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Careers That Change Lives


Evaluate device malfunctions and adverse events involving Diabetes products to determine Medical Device Report (MDR) eligibility. Identify and initiate product event investigations to satisfy MDR requirements as needed, according to established procedures. May function as department trainer or Quality Specialist or MDR Specialist. Conduct individual quality checks.

In this exciting role as a Product Reporting Specialist you will have responsibility for handling and evaluating incoming product complaints and product analysis results for Diabetes products to determine MDR eligibility. For investigating specific events by contacting internal resources, Medtronic field personnel and/or physicians/customers as appropriate. Ensuring the complaint files are complete and maintained properly to satisfactorily meet Quality System Regulations requirements and to comply with FDA requirements. Follow company policies, standard operating procedures (SOP) and department operating procedures (DOP) to ensure that complaint handling activities comply with the appropriate statutes and regulations. Present a professional manner and appearance.
DIABETES
Transforming diabetes care together, for greater freedom and better health.

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
ADVANCED INSULIN MANAGEMENT is focused on serving patients in need of insulin pump therapy. The Advanced Insulin Management (AIM) business unit is our history and our heritage and remains focused on driving increased automation to our insulin pump platform, to maximize the time people are within a set target glucose range. The ultimate goal is to develop a fully automated closed loop system .
NON-INTENSIVE DIABETES THERAPIES play a prominent role in our strategy to transform our business into a holistic diabetes management company. As we look to support patients across the disease continuum, it is critical for us to continue expanding our reach to type 2 patients in need of better diagnostic and monitoring solutions to manage their glucose levels.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.


A Day in the Life


  • Complaint review and MDR creation following department procedures
  • Ensure complaint investigations are adequate, accurate and timely
  • Evaluate complaints at various stages to determine if a Medical Device Report (MDR) is required
  • Active participation in change activities/process improvements
  • Submit MedWatch and Supplemental reports for timely submission to the FDA, using eMDR or eSubmitter when available
  • Must meet or exceed daily minimum productivity requirements

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.


  • Minimum of 4 years of relevant experience

Nice to Have

  • Experience in the medical field preferably in complaint handling and/or customer service
  • Demonstrated ability to communicate effectively in English over the telephone, in person, and in written form
  • Excellent reading comprehension in English
  • Ability to work productively and positively with team members
  • Computer proficiency
  • Competent with MS Office applications (Word, Excel, PowerPoint) and Outlook
  • Previous work experience in the medical field, preferably in complaint handling
  • Knowledge of Diabetes products
  • General knowledge of medical terminology
  • Quality focused with strong organization skills
  • Knowledge of 21 CFR Part 820, Quality System Regulations.
  • Knowledge of 21 CFR Part 803, Medical Device Reporting.
  • Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute
  • Knowledge of international medical device regulations
  • Degree or course work in Regulatory Compliance and/or Quality Assurance a plus

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information


  • Posting Date: Dec 2, 2020
  • Travel: No





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