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Senior Regulatory Affairs Program Manager

Medtronic
North Haven, CT 06473
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Senior Regulatory Affairs Program Manager

Location:

North Haven, Connecticut, United States

Requisition #:

220003LO

Post Date:

Mar 16, 2022


**REGULATORY AFFAIRS SENIOR PROGRAM MANAGER SURGICAL ROBOTICS**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


In the Surgical Robotics (SR) business, part of Medtronics Medical-Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to expand global access to care and reduce variability through robotic and analytics solutions.


**Careers that Change Lives:**


The **Regulatory Affairs Senior Program Manager** is responsible for leading key regulatory projects and initiatives within the Regulatory Affairs (RA) function for the Surgical Robotics Operating Unit.


This individual will drive continual improvement within the function through active engagement across Surgical Robotics RA and development of ideas and processes to drive efficiencies in Regulatory activities. The individual will work in collaboration with Regulatory Affairs team members, cross-functional members of the Operating Unit at many levels within the organization as well as global staff to ensure continuous improvements in the Regulatory function.


The role focuses on organizing workload within the RA function in coordination with a wide variety of stakeholders including product development, marketing, manufacturing, supplier quality, and global regional partners, and driving execution through the RA leadership team. The position requires the ability to balance strategic/tactical activities and communicate effectively with a large group of stakeholders. The Senior Program Manager is responsible for ensuring team commitments (scope, schedule and budget) are met and communicated in a timely manner and has the opportunity to influence decision and actions throughout the organization.


The role focuses on creating solutions to help Surgical Robotics Regulatory Affairs track and plan critical global compliance activities in addition to defining and maintaining relevant Regulatory Affairs data analytics. The Regulatory Affairs Senior Program Manager reports to the Senior Director of Regulatory Affairs.


**A Day In The Life:**


+ Work with Regulatory management and staff to determine, track and communicate key Regulatory metrics leveraging data analytics and visual management techniques.

+ Responsible for milestone/objective planning, communication, and deployment, and establishing tasks necessary for successful program execution and delivering results.

+ Align RA performance with the product development cycle, global registration demand, marketing strategy, and integrated business processes.

+ Partner with RA leadership team to ensure proper resourcing within the function.

+ Work with IT to automate systems data aggregation and perform data analytics to track execution of RA activities through well-defined KPI metrics (scorecards).

+ Attend various stakeholder meetings to represent the RA function, track progress, and provide status updates.

+ Apply and demonstrate strong leadership that results in a collaborative culture using clear, credible, objective and proactive communication and stakeholder management, including communication with executive staff.

+ Solve issues through information exchange, influence and active persuasion without direct exercise of command to gain the cooperation of other parties on program execution plans.

+ Communicate, lead meetings and conduct briefings to Regulatory Affairs staff andhigher-level management team.

+ Create and maintain a tracking and planning system for critical compliance activities, including global product renewals and registrations, product/system changes that impact global registrations and global portfolio to aid teams in resource planning. Work in partnership with other functions involved in strategic global portfolio management.

+ 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.

+ 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.

+ Additional responsibilities may be assigned


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 7 years of Program Manager experience

+ OR advanced degree with a minimum of 5 years of Program Manager experience


**Nice to Have**


+ Bachelors degree in Engineering, Business or Related Field

+ Experience in the medical industry, ideally the medical device or pharmaceutical industry.

+ PMP Certification or other formal Project Management training and experience.

+ General knowledge of Regulatory Affairs, Clinical, Quality Management Systems and compliance requirements for medical devices.

+ Excellent communication skills and interpersonal/team effectiveness ability to succinctly and accurately communicate to various levels of management and employees

+ Demonstrated capacity for strategic thinking, project planning and project management

+ Exceptional analytical, planning, organization and time management skills to effectively execute project plans and budgets

+ Exceptional program/project management skills; knowledge of process and project planning best practices

+ Business acumen; ability to think from an overall best for the business perspective

+ Demonstrates initiative; results-oriented

+ Excellent decision-making skills ability to negotiate and balance decisions and manage competing priorities across multiple functional areas

+ Experience with MS Project, MS Excel, MS PowerPoint and MS Word.

+ Experience in creating and delivering presentations to senior leadership.

+ Experience implementing initiatives through effective influence management skills at multiple levels in the organization

+ Analytical, process and data visualization experience

+ Flexible with changing priorities, self-motivated, strong work ethic, attention to detail, works well under pressure in a dynamic environment

+ Experience with tracking software tools (e.g. Power BI or others)

+ Exceptional analytical, planning, organization and time management skills to effectively execute project plans

+ Strong communication and interpersonal skills with experience working across functions and with global teams


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Physical Job Requirements**


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. (ADA-United States of America)
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.

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Posted: 2022-03-18 Expires: 2022-06-05
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Senior Regulatory Affairs Program Manager

Medtronic
North Haven, CT 06473

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