MDR/Vigilance Specialist at Medtronic in Lafayette, Colorado

Job Description:

We anticipate the application window for this opening will close on - 10 Jan 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
As an MDR/Vigilance Specialist you will help to ensure Medtronic's mission to improve human welfare and ensure reliability and quality in our products by ensuring timely and accurate complaint handling and regulatory reporting of our medical devices. You will be responsible for the intake, documentation, Medical Device Reporting (MDR), and investigation of complaints for Surgical products. You will be required to ensure compliance to applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies). You will be expected to understand what is required by our regulators for complaint handling and Medical Device Reporting and be able to learn quickly and work through/respond to complex issues.
Responsibilities include the following and other duties may be assigned.

• Receive and assess reported product events for Surgical products, timely, to determine requirement for complaint handling and MDR and Vigilance reporting eligibility


• Ensure required information is accurately documented in Medtronic's complaint handling database


• Ensure complete and accurate regulatory reporting as required by regulatory agencies (FDA / European Competent Authorities)


• Assess complaint file for missing required information. If information is missing, work with reporting individual/team to gather the needed information. Steps may include contacting:
  
  
  • Internal Medtronic Personnel
  
  
  • Health Care Providers or other initial reporters
  
  
  
  


• Act as a liaison internally and externally to respond to additional information request regarding reported events


• Ensure required training to Standard Operating Procedures and Work Instructions pertinent to this role are completed on time


• Provide guidance/suggestions and helps to training to fellow team members


• Help to ensure that Key Performance Indicators (KPIs) are met


• Provide technical expertise to optimize complaint processing systems


• Actively support other projects that enable process changes and improvements

Must Haves

• Bachelor's degree with 2+ years of experience in healthcare or medical device/pharmaceutical industry OR advanced degree

Nice to Have

• High level of computer proficiency (e.g. Microsoft Word, Microsoft Excel, SAP, Trackwise, etc.)


• Experience in healthcare or medical device/pharmaceutical industry supporting a quality assurance role


• Degree in Health Care, Sciences, or Bio-Medical Engineering


• Strong attention to detail


• Strong analytical skills (problem solving, critical thinking)


• Knowledge of basic anatomy, physiology, and medical terminology


• Knowledge of good documentation practices (GDP), good manufacturing practices (GMP) and quality systems in a regulated environment


• Self-starter and self-motivating


• Proficient in the English language


• Able to type proficiently and skilled at technical writing


• Excellent communication skills (oral and written), with strong organizational and analytical skills


• Ability to work independently or in a team setting


• Knowledge of Medical Device Regulations (i.e. FDA 21CFR, Section 820 and Quality System Regulation, 21CFR Section 803, EU Medical Device Reporting requirements)

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 Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$80,000.00 - $120,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.