Senior Principal Legal Counsel - FDA/Regulatory Law

 

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 LifeMedtronic Diabetes is seeking an FDA/Regulatory Law attorney with knowledge and experience of U.S. Food and Drug Administration (FDA) and global regulatory laws affecting medical device manufacturers. The role will support several of the company’s corporate functions, including Quality, Clinical, and Regulatory, and our regional partners around the globe. This individual will provide proactive legal advice and counsel managing risk on issues involving law and regulations regarding the total product lifecycle of medical devices, including design, clinical data, manufacturing, inspections, post market surveillance, and marketing and promotion on a global basis. Key attributes this individual must possess include strong legal and analytical skills and the ability to interact effectively with a variety of individuals in cross-functional roles in the organization. This role requires a high level of responsiveness to business and functional stakeholders in a large, dynamic, and fast-paced environment.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

This will be a remote role and will need to reside in the US.

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

• • Acting as strategic legal/business partner for the MiniMed business in substantive legal areas on issues of global government regulation and enforcement.   

  • Partnering with the business in conducting reviews of advertising and promotion collateral. 

  • Developing and revising policies, procedures, guidance, and tools related to advertising and promotion. 

  • Developing and delivering training content related to areas of FDA law as well as global regulatory laws and regulations. 

  • Supporting business leaders and the Quality function in developing and executing Issue Impact Assessments and Field Corrective Action Plans with respect to potential product quality issues and evaluating those issues for reportability under FDA and other regulatory requirements.   

  • Supporting leadership and the Quality function in drafting audit and inspection responses, including responses to FDA Form 483s and Warning Letters, if needed. 

  • Providing counsel to the Quality function on FDA Quality System Regulation requirements and supporting the development of appropriate Corrective and Preventive Actions (CAPAs). 

  • Partnering with the legal team and the Quality function to develop and review policies, procedures, guidance documents, and tools. 

  • Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to regulatory or quality matters.  

  • Delivering sophisticated legal regulatory expertise on quality and advertising and promotion issues; an understanding of regulatory trends, regulations, guidance and policies; and experienced perspective on how to calibrate risk and respond to related issues. 

  • Providing strong business-oriented solutions combined with deep quality and advertising and promotion expertise. 

   

  MUST HAVE: MINIMUM REQUIREMENTS:

  • Juris Doctor from a top tier national recognized law school 

  • Top tier law firm experience 

  • Licensed and in good standing to practice law in at least one state or the District of Columbia 

  • 8+ years of legal experience in FDA/life sciences regulatory law 

   

  NICE TO HAVE: 

  • Prior work experience at, or direct engagement with, the FDA 

  • Prior work experience in an in-house capacity at a global medical device manufacturer  

  • Ability to establish credibility and develop strong working relationships with clients 

  • Capable of and experienced in effectively working in groups and with senior management 

  • An understanding of business objectives, strategies, and relevant tactics 

  • Seasoned professional with good professional judgment 

  • Exceptional oral and written communication skills 

  • Strong team skills 

  • Experience advising on compliance with FDA and global regulations related to clinical trials 

  • Experience advising on compliance with FDA and global regulations related to medical devices 

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):$190,400.00 - $285,600.00This 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).

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 95,000+ 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.