Associate MDR/Vigilance Specialist

• →Receive and assess product comments to determine need for complaint handling record.
• →Document required information in Global Complaint Handling (GCH).
• →Assess complaint file for missing required information.  If information is missing, initiate attempts to gather information.  Steps may include contacting:
  • →Medtronic Field Personnel
  • →Health Care Providers
  • →Patients or other initial reporters
• →Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the Medtronic brand.
• →Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
• →Initiate and complete regulatory reports for timely submission to FDA and other regulatory bodies.
• →Determine if investigation is necessary.  If investigation is necessary, determine:
  • →Potential cause and contributing factors to the alleged event.
  • →Device relationship.
  • →If formal device investigation is necessary.
• →Summarize the results of any investigation.
• →Escalate complex issues to management.
• →Execute other projects as assigned.

• Bachelors degree with 0 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation 

• High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
• 0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation 
• Degree in Health Care, Sciences, or Bio-Medical Engineering
• Strong attention to detail
• Knowledge of basic anatomy, physiology, and medical terminology
• Knowledge of:
  • 21CFR, Section 820, Quality System Regulation
  • 21CFR Section 803, Medical Device Reporting
  • ISO 13485, Quality Systems, Quality Management Systems
  • 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
  • AIMD Directive: 90/385/EEC
  • IVD Directive: 98/97/EC
  • MDD Directive (Council Directive 93/42/EEC for Medical Devices)
  • PC 1998-783 - Canadian Medical Device Regulation (CMDR)
• Complaint handling experience or customer service/technical support experience (0-2 years)
• Strong analytical skills (problem solving, critical thinking)
• Excellent communication skills (oral and written), with strong organizational and analytical skills
• Ability to work independently or in a team setting

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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We are aware of phishing scams targeting job seekers. Please keep the following in mind: 

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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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

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.