Regulatory Affairs Manager - Neurovascular

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REGULATORY AFFAIRS MANAGER - PRODUCT LABELING
In the Neurovascular Operating Unit we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at: **** Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic both in the lives of others and your career.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers That Change Lives
As the Regulatory Affairs Manager for Product Labeling, you will have responsibility for managing product labeling projects supporting multiple labeling projects throughout the product lifecycle. Additionally, you will direct a team of Regulatory professionals.
**A Day In The Life**
Manage complex labeling-related projects, schedules, milestones, inter-dependencies, deliverables, and resources
Oversee labeling project teams and activities to meet business plan and quality requirements
Act as a point of contact for, and liaison to, functional and project managers for labeling planning, strategy, development, logistics, interdependencies, quality, etc.
Work with management and functional groups to ensure use of standard business processes and procedures to support compliance with federal and international regulations and industry standards.
Provide direction to technical writers within your project team.
Participate, or ensure team participation on, high-level product development team(s).
Coordinate/manage labeling project team work with all related functional groups and outside contractors and suppliers. Proactively communicate labeling interdependencies to project and project managers.
Serve as key communications contact with management to provide information and status on schedules, milestones, deliverables, etc., and to identify resource issues and needs.
Ensure labeling deliverables are on schedule.
Partner with Medtronic Translations to prioritize translation projects across projects, monitor translation progress, and communicate translation status to project and project managers. Partner with technical writers to develop project language strategy and partner with functional management to comply with new local language requirements.
Estimate labeling resource needs for individual projects and communicate to functional management during annual operation planning
Support key cross-functional and cross-business unit partnerships.
Partner with technical writing team to develop, communicate, and execute a labeling strategy for projects and projects. Seek input from a variety of functional areas and stakeholders on labeling project strategy.
Provide input on department process and practice efficiencies and internal department initiatives.
Occasionally own labeling CAPAs from investigation through closure.
Partner with technical writers to identify design inputs and create labeling product requirements.
Must Have; Minimum Requirements
BA/BS degree
Minimum with 5 years of medical device regulatory experience including project management.
Or a minimum 3 years of medical device regulatory experience including project management with an advanced degree.
Nice To Have
Supervisory experience preferred
Experience managing complex projects or projects, especially electronic products, labeling, medical devices or pharmaceuticals
Experience leading projects to completion
Excellent people and communication skills (verbal and written)
Strong organizational skills
Technical Writing experience in a regulated environment
Experience interacting with a broad range of functional groups and individuals at various levels of the organization
Experience managing multiple projects successfully
Experience using electronic tools for managing projects, routing reviews and approvals, allocating resources, etc.
5 years of experience in cross-functional, cross-geography project management
5 years of experience in a labeling creation environment
Experience working with cross-geography projects and teams
Experience working on projects requiring localization/translation
**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.
Categories
Healthcare
Management
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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