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Sr Director-Regulatory, Mechanical Circulatory Support (MCS)
We anticipate the application window for this opening will close on - 30 Nov 2024
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**
As a member of the Mechanical Circulatory Support (MCS) Leadership Team, the Senior Director of Regulatory Affairs leads a team of regulatory affairs professionals and requires a combination of deep regulatory experience, compliance expertise, technical aptitude, and business acumen. It will be critical that the candidate for this role be able to demonstrate an ability to work across all branches of our notified bodies to manage the regulatory process. In addition, the role depends on an ability to lead and motivate a team while building strong global relationships, both cross-functional and with global internal and external regulatory partners.
**A Day in the Life**
Reporting to the Vice President & GM of MCS, responsibilities may include the following and other duties may be assigned.
+ Provide strategic regulatory guidance to business leadership.
+ Develops and implements strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards.
+ Ensures comprehensive and compliant support of released products.
+ Develops and maintains ongoing relationships with global regulatory partners and regulatory authorities.
+ Establishes and maintains internal controls to ensure compliance as required by regulatory authorities.
+ Partners across the business and enterprise to continually improve processes related to regulatory activities.
+ Leads a strong, diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape.
+ Demonstrate an ability to leverage learning and experience therapy-to-therapy in gaining approvals and maintaining approved status.
+ Based in Miami Lakes, FL or Minneapolis, MN.
**Minimum Requirements "Must Have's"**
+ Bachelor’s degree in a scientific/technical field required.
+ For Bachelor's 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 18 years prior experience in regulatory affairs, clinical, quality and/or product development .
+ Masters or other advanced degree with minimum 15 years prior experience in regulatory affairs, clinical, quality and/or product development.
+ Minimum of 10 years of managerial experience in medical devices, specifically advanced management and leadership knowledge to lead cross-department project teams or manage across multiple functions.
+ Typically has achieved mastery within a specific technical or broad expertise across multiple related disciplines.
**Preferred Requirements "Nice to Have"**
+ 10+ years of Regulatory Affairs experience preferred, ideally in the cardiovascular space. Experience in other related functions such as clinical, quality or product development may be considered.
+ Regulatory / Compliance Expertise - Extensive regulatory knowledge and experience across a wide variety of product classifications; including higher classification devices (i.e. Class III PMA, Class III EU).- Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.- Ability to apply experience to develop complex strategies.- Ability to build and leverageexpertise across the bread the of the Medtronic enterprise regulatory function(s).- Experience in impactful negotiations with regulatory agencies.- Deep knowledge of pre- and post-market compliance requirements.- Experience partnering across functions on advertising and promotional activities.
+ Technical Aptitude-Background in a scientific or other technical discipline.- Excellent problem-solving skills and an ability to apply critical thinking.- Knowledge of product development processes and tools.- Application of significant working knowledge of other functional areas to identify and execute on opportunities for improvement.
+ Business Acumen- Significant experience as a member of senior business leadership teams.- Demonstrated ability to partner to resolve complex business challenges.- Ability to apply domain expertise and knowledge of regulatory environment to advise business on appropriate actions and future direction.- Influences across functions and businesses to negotiate and gain cooperation on divergent objectives.- Competency in management of departmental budget.
+ Communication/Leadership Skills- Demonstrated ability to develop and maintain strong, impactful relationships with global regulators.- Ability to clearly articulate a complex strategy.- Collaboration skills to partner with other functions to develop efficient approval strategies and resolve complex issues.- Confidence and impact in presenting to diverse audiences.- Ability to lead a team of experienced regulatory staff with responsibility for organizational structure and talent strategy ensuring skillsets evolve to meet the needs of the global regulatory landscape.
The above statements 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 Day in the Life section 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.
**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):$221,600.00 - $332,400.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.
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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic)
**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 (http://www.medtronic.com) .
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.
**Welcome to our new Careers Site!**
**If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.**
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.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will…
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
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