Regulatory Affairs Manager

About the Role

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, you will direct or perform coordination and preparation of document packages for regulatory submissions, internal audits and inspections. You will lead a team of experienced professionals while advancing regulatory compliance and healthcare innovation.

Responsibilities

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

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

People Management

Functional Career Stream: 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.

Key Responsibilities:

• 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
• Managing toward departmental goals
• Manages professionals who exercise latitude and independence in assignments
• Provides tactical and / or operational leadership and coaching
• Receives assignments in task and objective oriented terms

Autonomy:

Manages professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.

Organizational Impact:

Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. Strive for continuous improvement and consistency in deliverables.

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.

Communication and Influence:

Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties. May interact on issues that have externally shared objectives.

Leadership and Talent Management:

Manages a team consisting of experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.

Required Knowledge and Experience

• Bachelor degree; Engineering or Science degrees preferred (e.g. 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
• 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.

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

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 95,000+ 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.

We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are.

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work.

Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

By bringing your ambitious ideas, unique perspective and contributions, you will:

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

• Experiences that put people first: Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
• Life-transforming technologies: No matter your role, you contribute to technologies that transform lives.