Associate MDR/Vigilance Specialist

Medtronic•Mounds View, MN

3d•Onsite

About The Position

Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies). At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

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

Nice To Haves

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

Responsibilities

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.

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)