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Principal Legal Counsel - Environmental & FDA

We anticipate the application window for this opening will close on - 3 Jan 2025At 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 LifeThis individual will be part of a corporate, shared-service team of lawyers that combines deep substantive expertise in regulatory areas core to Medtronic’s business with in-house understanding of Medtronic’s businesses. Team members work across multiple operating units, manufacturing and geographies resulting in unique ability to 1) advise businesses on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. This position reports to the Senior Legal Director- Environmental, Health & Safety/Dangerous Goods-Enterprise Legal Regulatory.This position could reside in Minneapolis, MN or one of our other US Medtronic office locations, or alternate (remote) location to be discussed.Responsibilities for this position include:• Acting as strategic legal partner for the Medtronic businesses in substantive legal areas on issues of government regulation and enforcement while serving on a strong Corporate-level team of in-house EPA lawyers and technical professionals.• Advising Medtronic Corporate and Operating Unit Legal, Global Operations and Supply Chain, Quality, Regulatory, Environmental, Health and Safety, Transportation, Dangerous Goods and other functions on substantive issues related to regulatory authority inspections, and associated communications with regulators.• Advising Medtronic Corporate and Legal, Operations and Corporate Environmental, Health & Safety, Regulatory, Dangerous Goods team and other functions on materials of concern testing and reporting issues.• Advising Medtronic Corporate and Operating Unit functions on policies, procedures and risk mitigation practices associated with materials of concern and product stewardship issues.• Advising Corporate and Operating Unit functions on notices of violation, complaint letters, findings and other regulatory authority requirements related to manufacturing operations and product sales and marketing.• Partnering with Medtronic Corporate and Operating Unit Environmental, Health & Safety, Product Stewardship, Sustainability and Dangerous Goods/Transportation functions to develop policies, procedures, legal guidance documents, tools and training materials.• Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to environmental, health and safety, dangerous goods or transportation matters.• Identifying and driving mitigation of risks that cross Medtronic businesses and facilitating information sharing across and among Medtronic businesses.• Assisting M&A team with due diligence in significant substantive areas.• Advising on toxic tort litigation matters relating to historic environmental issues in Medtronic businesses.• Monitoring the external regulatory and enforcement environment to identify emerging risks to the company.• Developing expertise and applying knowledge in discrete areas of state and/or federal regulation (e.g. state and federal licensing requirements) as they pertain to Medtronic products and businesses.MUST HAVE: MINIMUM REQUIREMENTS:• Juris Doctor from nationally recognized Law School• Licensed to practice law in at least one state or the District of Columbia• 5+ years of legal experience in sustainability and environmental, health & safety law counseling with litigation experience or similar experience.NICE TO HAVE:• Experience in counseling on environmental regulatory compliance matters• Experience in counseling on health and safety compliance• Experience in counseling on sustainability issues including greenwashing claims• Experience in managing environmental remediation sites• Experience in counseling on global transportation and dangerous goods matters• Experience in various international environmental product directives and guidance (REACH, RoHS, SCIP)• Experience in counseling on U.S. Food and Drug Administration (FDA) regulatory requirements• Experience in conducting reviews of advertising and promotional materials for FDA regulated products and applying associated policies, procedures, and guidance• 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 communications skills• Strong team skillsPhysical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$156,800.00 - $235,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).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 plansAbout MedtronicWe 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.
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$156800K
$235200K

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What You Should Know About Principal Legal Counsel - Environmental & FDA, Medtronic

At Medtronic, we're on a mission to transform healthcare, and we're looking for a Principal Legal Counsel - Environmental & FDA to join our dynamic team in Denver, CO. This role is not just about providing legal advice; it's about being a strategic partner in navigating complex regulations that impact our innovative healthcare solutions. Imagine being at the forefront of environmental, health, and safety law, working closely with professionals who are just as passionate about making a difference in healthcare as you are! You'll collaborate with various teams across multiple operating units, providing insights on regulatory inspections and helping shape policies that not only comply with the law but also promote sustainability and product stewardship. Your expertise will be crucial in identifying risks and developing training materials that empower our teams to navigate the regulatory landscape effectively. If you're someone who thrives in a corporate environment, has extensive experience in environmental law, and sees the potential for innovation in compliance, then this could be the perfect opportunity for you to make an impact while advancing your career. Plus, we offer competitive compensation and a range of benefits that can support both your career growth and your work-life balance. If you're ready to lead with purpose and make a tangible difference, we can't wait to meet you!

Frequently Asked Questions (FAQs) for Principal Legal Counsel - Environmental & FDA Role at Medtronic
What are the responsibilities of a Principal Legal Counsel - Environmental & FDA at Medtronic?

As a Principal Legal Counsel - Environmental & FDA at Medtronic, you will advise various business units on complex legal issues regarding regulatory compliance related to environmental, health, and safety laws. You'll also handle compliance investigations, develop policies for materials of concern, provide support during regulatory authority inspections, and work alongside M&A teams on due diligence.

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What qualifications are required for the Principal Legal Counsel position at Medtronic?

To qualify for the Principal Legal Counsel - Environmental & FDA position at Medtronic, candidates must possess a Juris Doctor from a recognized law school and be licensed to practice law in at least one state or the District of Columbia. Additionally, a minimum of five years of experience in sustainability and environmental law along with litigation experience is required.

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What does a typical day look like for a Principal Legal Counsel - Environmental & FDA at Medtronic?

A typical day as a Principal Legal Counsel - Environmental & FDA at Medtronic involves collaborating with cross-functional teams on regulatory compliance issues, attending meetings to discuss legal strategies, analyzing complex regulations, and advising on policy development. You’ll also spend time staying updated on emerging risks in the regulatory environment.

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What skills are important for a Principal Legal Counsel - Environmental & FDA at Medtronic?

Key skills for a Principal Legal Counsel - Environmental & FDA at Medtronic include strong communication and analytical skills, the ability to establish relationships with clients, experience in providing legal counsel on environmental matters, and an understanding of business operations. A proactive approach to identifying and mitigating risks is also essential.

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What benefits are offered to Medtronic's Principal Legal Counsel - Environmental & FDA?

Medtronic offers a competitive salary for the Principal Legal Counsel - Environmental & FDA role, along with benefits such as health, dental, and vision insurance, a 401(k) plan with employer contributions, tuition assistance, and a well-being program. We strive to ensure our employees feel supported throughout their career journey.

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Common Interview Questions for Principal Legal Counsel - Environmental & FDA
How do you prioritize regulatory compliance issues in your work as a Principal Legal Counsel?

In my experience, prioritizing compliance involves understanding the potential risks and impacts of each issue. I assess factors such as legal exposure, business objectives, and stakeholder implications to develop a focused approach. This method ensures that the most pressing concerns are addressed promptly.

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Can you describe your experience with EPA regulations as they relate to Medtronic’s operations?

I have significant experience interpreting and providing guidance on EPA regulations, particularly in relation to environmental inspections and compliance. I ensure that my teams remain informed and prepared for any regulatory changes impacting our operations.

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How would you approach advising clients on materials of concern testing and reporting?

I would begin by assessing the specific regulatory requirements that apply to the materials in question. Then, I would work closely with the relevant business units to develop testing protocols and reporting processes that ensure compliance while also addressing any potential risks.

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What role do you think collaboration plays in the effectiveness of legal counsel in a corporate setting?

Collaboration is essential in legal counsel roles, as it fosters a comprehensive understanding of business needs and helps anticipate regulatory challenges. Engaging with cross-functional teams enables me to provide more impactful legal advice that aligns with the company’s objectives.

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How do you stay informed about changes in environmental and FDA regulations?

I prioritize continuous learning by subscribing to legal journals, attending relevant seminars, and participating in professional associations. Networking with other professionals in the field also helps me stay updated on regulatory changes and best practices.

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Describe a challenging compliance issue you've faced and how you resolved it.

I once dealt with a significant compliance issue involving new regulatory requirements impacting a major product line. I coordinated with various departments to analyze the implications and developed a comprehensive compliance strategy that included training sessions and ongoing monitoring.

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What experience do you have with toxic tort litigation matters?

I have worked on several toxic tort cases involving historical environmental issues. My role often included analyzing evidence, preparing legal documents, and collaborating with external legal teams to ensure an effective defense strategy.

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How do you approach risk mitigation in your legal counsel duties?

I conduct thorough assessments of potential legal risks within the organization and collaborate with business units to devise proactive strategies. This includes creating clear policies, ensuring employee training, and allowing for open communication regarding potential concerns.

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What do you believe is the most important attribute for a Principal Legal Counsel at Medtronic?

The most crucial attribute is integrity—finding the balance between providing sound legal counsel and advancing the business’s goals. Trust and credibility with both clients and team members are vital in ensuring effective legal operations within the company.

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How would you handle a regulatory authority investigation?

Engaging immediately with involved parties to gather relevant information is key. I would coordinate with various departments to ensure proper documentation and compliance while remaining transparent with regulatory authorities throughout the investigation process.

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Mission Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees aroun...

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December 23, 2024

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