MDR / Vigilance Manager - Regulatory and Audit

Medtronic   •  

Mounds View, MN

Industry: Manufacturing

  •  

5 - 7 years

Posted 37 days ago

Careers that Change Lives

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

In this role you will be a key member of the Product Experience Management team, with a focus on the regulatory and audit areas for our department. In addition to that area of focus, you will be responsible for managing processes, analytics and staff within the CVG- CRHF compliant handling and medical device reporting process. You will identify, lead and coordinate cross-functional activities representing the CVG PXM organization to ensure regulatory compliance, increased quality, efficiencies and collaboration with key stakeholders and internal business partners.

This role will be expected to work on occasion outside of normal business hours to meet the needs of global business partners.

The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

- You will have oversight of the audit, regulatory and quality management areas of the department- with a focus on audit and regulatory strategy and execution

-You will represent the complaint handling process to external regulators and internal auditors

-You will identify and lead department initiatives that result in the resolution of CVG PXM opportunities to increase

operational efficiency, quality, consistency, compliance and cost effectiveness

- You will support the preparation of CVG reports and analytical tools that will be used for internal decision making,

potential reporting to regulatory agencies, and fulfilling business partner queries

- You will lead preventative and corrective action activities

- You will serve as the manager of the team and actively contribute to talent acquisition and talent management for the department

- You will participate in the Annual Operating Plan and develop and administer budgets, schedules and performance

standards

- You will monitor the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations

- You will ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

- You will review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the

creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries

- You will act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

Must Have: Minimum Requirements

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

  • Bachelors Degree with 5+ years of experience in complaint handling, MDR/Vigiliance and/or Quality, or Masters degree with 3+ years of experience in complaint handling, MDR/Vigiliance and/or Quality.
  • Prior experience in Medical Device Industry

Nice to Have

Experience managing and leading FDA inspections and responses

Experience leading Front and Back Room Audits

Knowledge of Global Regulations

Bachelor’s degree in healthcare, engineering or bioscience field

Experience managing or supervising a team

Experience leading complaint teams and adverse event reporting

Knowledge of Cardio Vascular products

Strong verbal and written communication skills

Experience working with international business partners

Experience integrating business groups


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 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. (ADA-United States of America)

This position will require up to 25% Travel, domestic and international.

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