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

Responsibilities may include the following and other duties may be assigned

• Directs or coordinates the preparation of document packages for regulatory submissions
• Leads or supports team to compile all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications
• Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area.
• The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports.
• Goal achievement is typically accomplished through performance of direct and / or indirect reports.
• A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

Required Knowledge and Experience

• Bachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)
• 12+ years of regulatory experience in medical or pharmaceutical industry.
• Minimum 3 years of people leadership experience in handling medium to large size teams.
• Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis
• Strong typing skills and ability to write business documents with minimal supervision.
• Strong verbal and written communication skills and ability to work in a team oriented environment
• Ability to be proactive and lead initiatives technically
• Ability to multitask.
• Ability to understand the functionality / intended use of complex medical devices.
• Minimum travel may be required 

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. 

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.
 

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