ICT Lead Legal Counsel (Digital), Mounds View, MN

Medtronic•Minneapolis, MN

2d•$191,200 - $286,800•Hybrid

About The Position

Provide legal support for the Interventional Cardiology Therapies Business, with demonstrated ability to collaborate and partner with business leaders regarding business strategy and related legal and compliance issues. This role carries a particular focus on the Business’s digital health portfolio, partnering directly with digital health program leaders and software development core teams. Strong interaction and collaboration with other Legal Department team members, including Legal, Privacy, and Compliance Centers of Expertise (COEs) and Regional Legal team members. Strong interaction and collaboration with other Medtronic functions, including: marketing, sales, regulatory affairs, quality, research and development, business development, clinical, office of medical affairs, finance, human resources, communications, information security, and operations. Proven ability to effectively manage multiple priorities with a sense of urgency while working within the Medtronic Mindsets and Mission. Manage and deliver legal advice and counsel to legal, business, function, and regional stakeholders. Maintain a trusted seat at leadership team meetings and operating mechanisms for the business and ensure the business receives the legal advice needed to make key business decisions and manage cross-functional legal and compliance risks appropriately. Serve as the legal advisor to digital health programs and software development core teams, supporting advisement on regulatory, privacy, data protection, and commercial risk throughout the product development lifecycle. In close collaboration and alignment with OPIC privacy partners, including, Global Privacy Advisors and Global Privacy Legal, counsel R&D and product teams on Privacy by Design legal requirements, advising on the legal aspects of data protection impact assessments and the selection of appropriate privacy and data-handling controls from the latest version of the OPIC Privacy Control Objectives (PCOL) Library. In close collaboration and alignment with Global Privacy Legal, assist with drafting and negotiating privacy- and data-related contractual terms, including data processing agreements, consent language, and third-party / vendor risk provisions. Provide connection with OPIC privacy partners, including Global Privacy Advisors and Global Privacy Legal team, information security, and regulatory affairs on incident response, customer privacy and security inquiries, and medical device cybersecurity regulatory expectations. Collaborate and partner closely with OPIC privacy partners, including Global Privacy Legal and assigned Global Privacy advisors to align legal guidance, support cross-border issues, and drive consistent, practical privacy solutions for the business. Ensure appropriate privacy documentation is completed and maintained within the OPIC Privacy system of record, including DPIAs, PIAs, ROPAs, and other required privacy artifacts. Coordinate and partner with COEs, regional partners, and outside counsel to ensure high quality legal support. Engage appropriate stakeholders across the enterprise to drive consistency in approach as appropriate. Lead stakeholders in the development and implementation of relevant training and knowledge management programs. Serve as legal counsel for business development projects involving due diligence, acquisitions, joint ventures, and integrations. Implement continuous improvement of operating mechanisms. Guide, develop, and support Legal Department team members. Engage in knowledge sharing with other legal leaders across the Enterprise. Build consensus and navigate cutting-edge legal issues.

Requirements

Juris Doctor (J.D.) from a nationally accredited law school with strong academic credentials
8+ years of experience as an Attorney in intellectual property law discipline
Licensed to practice in at least one US state or the District of Columbia
Registered to practice before the U.S. Patent and Trademark Office

Nice To Haves

Demonstrated experience providing legal business advisement on digital health programs, data privacy and protection, and/or software development core teams in a regulated environment
Strong understanding of, and ability to demonstrate, the following cultural norms: act boldly; compete to win; move with speed & decisiveness; foster belonging; and deliver results the right way
Medical device, digital health, or other heavily regulated industry experience
Demonstrated experience advising digital programs and software development core teams, including working alongside product and engineering teams in an advisory legal capacity
Working knowledge of global privacy and data protection laws (e.g., HIPAA, GDPR, U.S. state privacy laws) and their application to medical devices and digital health products
Familiarity with Privacy by Design principles and integrating privacy and legal requirements into product development lifecycles
Experience advising on artificial intelligence / machine learning governance and software as a medical device (SaMD)
Working understanding of medical device cybersecurity regulatory frameworks and standards (e.g., FDA pre- and post-market cybersecurity guidance, ISO 13485, IEC 81001-5-1)
Experience drafting and negotiating data processing agreements, consent frameworks, and third-party / vendor risk provisions
Excellent written and verbal communication skills, including the ability to communicate complex and technical information in a clear and engaging way to diverse audiences
Demonstrated strong analytical thinking ability
Flexibility, adaptability, pragmatism, responsiveness and collegiality
Ability to work on multiple projects at the same time
Superior common sense and judgment
Courage, integrity and strong ethical character
Analytical risk identification, evaluation, and management skills
Capable of inspiring trust and confidence in business partners

Responsibilities

Provide legal support for the Interventional Cardiology Therapies Business, with demonstrated ability to collaborate and partner with business leaders regarding business strategy and related legal and compliance issues.
This role carries a particular focus on the Business’s digital health portfolio, partnering directly with digital health program leaders and software development core teams.
Strong interaction and collaboration with other Legal Department team members, including Legal, Privacy, and Compliance Centers of Expertise (COEs) and Regional Legal team members.
Strong interaction and collaboration with other Medtronic functions, including: marketing, sales, regulatory affairs, quality, research and development, business development, clinical, office of medical affairs, finance, human resources, communications, information security, and operations.
Proven ability to effectively manage multiple priorities with a sense of urgency while working within the Medtronic Mindsets and Mission.
Provide strong commercial legal advice and also step in to provide support across the larger Interventional Cardiology Therapies Business in substantive areas of the law, including: negotiation and drafting of a wide array of strategic commercial contracts; healthcare compliance; competition law; regulatory law; product liability; data privacy & protection; distribution and agency law; labor & employment law; corporate governance; mergers & acquisitions; and a basic understanding of intellectual property and litigation issues, as required.
Serve as ICT’s legal point of contact for digital health and connected-device initiatives, advising digital health programs and software development core teams across the product lifecycle.
Work on business teams to identify and provide basic level legal business support on data privacy and protection, software as a medical device (SaMD), artificial intelligence and machine learning governance, and medical device cybersecurity issues, in alignment with the applicable COEs, acting as a translator and connector between the business teams and the privacy business partners, privacy legal advisors, information security, and regulatory affairs to ensure privacy and data protection risks are identified, evaluated, and appropriately mitigated.
Manage and deliver legal advice and counsel to legal, business, function, and regional stakeholders.
Maintain a trusted seat at leadership team meetings and operating mechanisms for the business and ensure the business receives the legal advice needed to make key business decisions and manage cross-functional legal and compliance risks appropriately.
Serve as the legal advisor to digital health programs and software development core teams, supporting advisement on regulatory, privacy, data protection, and commercial risk throughout the product development lifecycle.
In close collaboration and alignment with OPIC privacy partners, including, Global Privacy Advisors and Global Privacy Legal, counsel R&D and product teams on Privacy by Design legal requirements, advising on the legal aspects of data protection impact assessments and the selection of appropriate privacy and data-handling controls from the latest version of the OPIC Privacy Control Objectives (PCOL) Library.
In close collaboration and alignment with Global Privacy Legal, assist with drafting and negotiating privacy- and data-related contractual terms, including data processing agreements, consent language, and third-party / vendor risk provisions.
Provide connection with OPIC privacy partners, including Global Privacy Advisors and Global Privacy Legal team, information security, and regulatory affairs on incident response, customer privacy and security inquiries, and medical device cybersecurity regulatory expectations.
Collaborate and partner closely with OPIC privacy partners, including Global Privacy Legal and assigned Global Privacy advisors to align legal guidance, support cross-border issues, and drive consistent, practical privacy solutions for the business.
Ensure appropriate privacy documentation is completed and maintained within the OPIC Privacy system of record, including DPIAs, PIAs, ROPAs, and other required privacy artifacts.
Coordinate and partner with COEs, regional partners, and outside counsel to ensure high quality legal support.
Engage appropriate stakeholders across the enterprise to drive consistency in approach as appropriate.
Lead stakeholders in the development and implementation of relevant training and knowledge management programs.
Serve as legal counsel for business development projects involving due diligence, acquisitions, joint ventures, and integrations.
Implement continuous improvement of operating mechanisms.
Guide, develop, and support Legal Department team members.
Engage in knowledge sharing with other legal leaders across the Enterprise.
Build consensus and navigate cutting-edge legal issues.