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Sr. Regulatory Affairs Program Manager

Medtronic
United Statesfull_timeVerifiedPosted 14 Aug 2025
💰 $231,600/yr

About the role

We anticipate the application window for this opening will close on - 21 Aug 2025


 

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 areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Oversees and/or conducts comprehensive reviews of promotional materials
  • 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.

PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility, managing program/team performance, communicating project and operational developments, planning, prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.

DIFFERENTIATING FACTORS

Autonomy: Manages one or more medium-scale, established programs with generally-defined program plans and delivery methodologies.
Is accountable for overall program process, performance, and customer satisfaction.

Organizational Impact: Participates in establishing program objectives, timelines, milestones, and budgets .
Develops new policies and procedures that affect program management.
Typically has budget accountability for one or more programs.
Program decisions are generally recommended to higher level management.

Innovation and Complexity: Problems and issues faced are difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
Problems typically impact multiple workstreams, departments or specialties .
Enhances programs management processes to improve program.

Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.
Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties on program objectives and execution plans .

Leadership and Talent Management: Leads, directs and reviews the work of a team of managers, experienced professionals and/or vendors who exercise latitude and independence in their assignments.
Establishes daily tasks necessary for successful program execution.
Not directly responsible for hire or fire decisions and people management.

Required Knowledge and Experience: Requires broad management knowledge and experience to lead project teams in one department.
Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.

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.

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Company

Medtronic

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