Senior Regulatory Affairs Manager at Medtronic in Lafayette, Colorado

Job Description:

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


• Leads or compiles all materials required for submissions, license renewals, and annual registrations.


• Responsible for developing global regulatory strategies for new and existing products


• 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.


• Direct interaction with regulatory agencies on defined matters.


• Recommends regulatory strategies for earliest possible approvals globally


• Responsible for the management and supervisory professionals with one or more employees focused on tactical, operational, and strategic activities within a specified area.


• 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.
  
  
  
  


• 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 directing the responsibilities of direct reports.


• Leads the strategy development for own department or business area, ensuring links to the company's aims and objectives.


• Management authority to make significant business decisions and some strategic decisions. Decisions impact the financial performance, employees, or public image of the operational unit and company.


• Typically, it has budget or P&L accountability for a department, a broad functional area, or a geography.


• Drives innovation across the business area, encouraging best practices and knowledge sharing.


• Significantly improves, changes, or adapts own department or business area's processes, systems, products, or services.

Must-Have: Minimum Requirements

• Bachelors degree


• Minimum of 7 years of regulatory affairs experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience with 5+ years of managerial experience.

Nice to Have.

• Direct experience working directly with regulators and notified bodies globally.


• Experience working across multiple businesses and teams to achieve aligned goals


• Strong communication skills


• Regulatory experience with implants and software.

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.

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.

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.

Salary ranges for U.S (excl. PR) locations (USD):$143,200.00 - $214,800.00

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

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

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 .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.