Regulatory Affairs Manager Healthcare

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.

In this exciting role as a Regulatory Affairs Manager, 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.

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

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.

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. 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.

Provides tactical and / or operational leadership and coaching. Organizational Impact: Establishes operational plans and implements policies and strategies. Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.

Communicates with internal and external customers and vendors regarding ongoing operations. Leadership and Talent Management: Manages a team consisting of experienced professionals in the Specialist career stream. Required Knowledge And Experience

• Bachelor degree; SW,EE, ME, Biomedical Engineering)
• 15+ years of regulatory experience in medical or pharmaceutical industry.
• Minimum 5 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.
• Ability to understand the functionality / intended use of complex medical devices.
• Minimum travel may be required

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate 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