Medtronic
Senior Regulatory Affairs Manager - Surgical Robotics (Finance)
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. 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. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers That Change Lives
The Senior Regulatory Affairs Manager reports to the Sr Director of Regulatory Affairs for Surgical Robotics and is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Robotic-Assisted Surgery (RAS) products.
This position is responsible for providing direction and leadership to Regulatory Affairs Specialists in the development of regulatory strategies and processes to assure timely global commercialization of RAS products in compliance with applicable regulations and standards. The successful senior manager will be a strategic partner for our R&D and Marketing teams, as well as effectively collaborate with International RA, Clinical, Quality, Manufacturing Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle. The successful senior manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees. The senior manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role provides leadership, coaching and career development for team members and positively contributes to the development and maintenance of a collaborative and successful culture. This position is responsible for managing the work priorities and career development of direct reports who are focused on strategic, tactical, and operational activities pertaining to obtaining and maintaining major market regulatory product approvals. These responsibilities are performed through the collaboration with various functions across the Surgical Robotics Operating Unit (OU), including but not limited to Regulatory Affairs, Research and Development, and Quality and Marketing.
The Sr Manager of Regulatory Affairs for Surgical Robotics provides management to the Surgical Robotics Regulatory Affairs department in such areas as strategic work direction, training, mentoring and regulatory advice. Specifically, this role provides advice on submission strategy, engages in regulatory activities, and supervises the preparation of submission deliverables to facilitate the introduce of new products to the global market.
Management responsibilities include interviewing and hiring, managing performance, developing talent, driving engagement and inclusion, communicating business and operational requirements, and project planning.
Individual and business goals and performance objectives are achieved through hands on and delegation of responsibilities to individual contributors.
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintaining proficiency in global regulatory requirements. The successful candidate will be able to deal with advanced concepts and undefined paths, develop new solutions based on experience and working collaboratively with other functions, OUs and Regions.
This position is based in the Boston, MA office or is remote.
A Day In The Life
Must Have; Minimum Requirements
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. Let's 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)
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.
Learn more about our benefits: benefits.medtronic.com
This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .
Additional Information