Senior MDR/Vigilance Supervisor

Medtronic•Minneapolis, MN

5d•Onsite

About The Position

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 Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The Senior MDR/Vigilance Supervisor is responsible for the oversight of complaint handling, medical device reporting, and investigation of complaints for Cardiac Rhythm Management (CRM) products in accordance with applicable internal procedures and work instructions, and external requirements (regulations or guidance from any and all regulatory bodies). The MDR/Vigilance Supervisor provides resource coordination and work allocation for team members to meet daily and monthly goals, supports problem solving activities to drive continuous improvement, provides performance management and talent development of team members, and promotes an engaged culture. Responsibilities may include the following and other duties may be assigned. 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. 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. 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. Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. Supervises team members or subordinate supervisors, providing tactical and / or technical leadership. Plan and establish goals and objectives for a team, typically within (1) department. Make improvements to processes, systems or products. Communicate with internal and external customers and vendors, across various levels of the organization. Lead, direct and review the work of team members in order to accomplish operational plans and results. 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 4 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

Requires a Bachelors degree and minimum of 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience.

Nice To Haves

Previous complaint handling experience in the Customer Quality (CQ) organization
Bachelor degree with 6+ years’ experience in healthcare, medical device, or pharmaceutical industry
Leadership experience and the ability to lead a large team setting
Ability to work well under pressure with a positive enthusiastic attitude
Strong attention to detail
Excellent communication skills (oral and written), with strong organizational and analytical skills
Experience with data analytics/metric report production, and report out to team and leadership
Audit experience
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
MDD Directive (Council Directive 93/42/EEC for Medical Devices)
Knowledge of or experience with problem-solving and process-improvement methodologies
Knowledge of cardiovascular medical device products
High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)

Responsibilities

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.
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.
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.
Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Supervises team members or subordinate supervisors, providing tactical and / or technical leadership.
Plan and establish goals and objectives for a team, typically within (1) department.
Make improvements to processes, systems or products.
Communicate with internal and external customers and vendors, across various levels of the organization.
Lead, direct and review the work of team members in order to accomplish operational plans and results.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)