Vice President, Regulatory Affairs - Neurovascular at Medtronic in Irvine, California

Job Description:

We anticipate the application window for this opening will close on - 13 Dec 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
In the Neurovascular (NV) Operating Unit, we continuously innovate to provide meaningful tools and technologies to do more for stroke patients. Our comprehensive portfolio provides Neurovascular solutions that advance and enhance care. In addition, we continuously pursue strategic partnerships that round out the continuum of care giving patients the holistic care they deserve through our innovative, integrated solutions.

We work with interventional neuroradiologists, neurologists, neurosurgeons and other stakeholders to optimize stroke treatment. We have the largest portfolio of products for both hemorrhagic and ischemic stroke on the market, allowing us to offer total solutions to our customers.

Reporting to the Neurovascular Operating Unit President, the VP, Regulatory Affairs (RA) leader is responsible for creating an annual and long-term strategic regulatory affairs plan to advance the Neurovascular Operating Unit.

As a member of the Neurovascular Leadership Team, the Vice President of Regulatory Affairs leads a team of regulatory affairs professionals with responsibility for securing and maintaining approvals for a broad set of products and systems supporting a global product portfolio.

The NV portfolio comprises many product classifications including active implantable systems and combination products. As a result, this Vice President of Regulatory Affairs role requires a combination of deep regulatory experience, compliance expertise, technical aptitude, and business acumen. It will be critical that the candidate for this role demonstrates strong knowledge of global regulator expectations and an ability to work directly with the FDA, Notified Body and Competent Authority regulators, as well as closely collaborate on strategy for China along with other global markets. In addition, the role depends on an ability to lead and motivate a large team while building strong global relationships, both cross-functional and with global internal and external regulatory partners.

Responsibilities may include the following and other duties may be assigned.

• Provide strategic regulatory guidance to business leadership.

• Develop and implement strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards.

• Ensure comprehensive and compliant support of released products.

• Develop and maintain ongoing relationships with global regulatory partners and regulatory authorities.

• Establish and maintain internal controls to ensure compliance as required by regulatory authorities.

• Partner across the business and enterprise to continually improve processes related to regulatory activities.

• Lead 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.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• B achelor's degree in scientific/technical field required ; (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 18 years prior experience in regulatory affairs, clinical, quality and/or product development

• With Masters or other advanced degree, minimum 15 years prior experience in regulatory affairs, clinical, quality and/or product development

• Minimum of 15 years of managerial experience in medical device industry

Nice to Have

• 10+ years of Regulatory Affairs experience preferred, ideally in the vascular or neuroscience 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 including significant clinical activities

• Ability to build and leverage expertise across the bread the of the Medtronic enterprise regulatory function(s)

• Experience in impactful negotiations with regulatory agencies

• Deep knowledge of global pre- and post-market regulatory 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

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):$243,000 - $406,000

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. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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 .

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.