With over 400M connected medical devices worldwide and the value of the healthcare Internet of Things (IoT) market valued at $163 billion, it’s no surprise that venture funding in the Digital Health space has hit record highs year after year. What’s clear is that all of healthcare’s future products – medical devices, combination products, wearables, Software as Medical Device and more – will all be digitally driven.

A leader in the digital health space is BrightInsight, the VC-backed Silicon Valley startup that provides the leading global regulated IoT platform for the world’s top biopharma and medtech companies.

We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the regulated healthcare space. We are passionate about what we do and wholeheartedly believe in our vision to transform patient outcomes globally by bringing the power of digital technology to healthcare.

Since launching the BrightInsight Platform in 2018, we have secured a number of top-tier customers, including announcements with 2 of the world’s top 20 biopharma companies. Our award-winning platform was selected as the “Best IoT Healthcare Platform” in the 2019 MedTech Breakthrough Awards, the “2018 Google Cloud Partner of the Year for Healthcare and Life Sciences,” was featured as the cover story for CIOReview Magazine’s “20 Most Promising Biotech Solution Providers 2019," and was included in The Journal of mHealth's “2020 Global Digital Health 100”.

If you enjoy working with solution-oriented, driven colleagues in an agile, bureaucratic-free environment, then come join us at BrightInsight as our Senior Commercial Counsel.

About the job

BrightInsight develops web-based and mobile apps as regulated medical devices for our pharma and medical device customers, and we provide a robust, secure platform on a SaaS basis to host our customers’ apps, process health-related personal data, and run algorithms that provide actionable insights to improve patient health and manage medical conditions.

Core responsibilities include:

  • Drafting and negotiating regulated SaMD (software as a medical device) agreements, including enterprise SaaS, software development, data privacy, business associate, and quality agreements, terms of use, and a wide range of agreements such as consulting and other professional services, vendor and outsourcing services, marketing, confidentiality, etc.;
  • Advising and ensuring that internal clients receive sound, practical, and timely legal advice on a wide variety of legal matters related to BrightInsight’s business providing a regulated digital health platform and professional services (including software development) to pharmaceutical and medical device companies;
  • Maintaining familiarity with relevant laws, including those related to privacy (HIPAA, GDPR, CCPA); FDA regulations governing SaMDs and international regulatory regimes; intellectual property; product liability; sales and marketing to healthcare professionals and government reimbursement such as fraud and abuse (Anti-Kickback Statute, False Claims Act), and anti-corruption (Foreign Corrupt Practices Act);
  • Resolving legal issues using negotiation skills and providing proactive legal advice to key business leaders on issues of concern to BrightInsight;
  • Assisting with U.S. and international compliance initiatives;
  • Developing knowledge of BrightInsight’s business, products, and services;
  • Representing BrightInsight externally to customers and suppliers;
  • Helping direct the work of outside counsel, defining project objectives, managing projects, and monitoring outside counsel to ensure they operate within budget;
  • Gathering and consolidating input from multiple sources; and
  • Managing contract process and database, tracking metrics and throughput.

The successful candidate must possess:

  • Strong knowledge of U.S. digital health, data privacy, intellectual property, and commercial law, and familiarity with international equivalents;
  • Demonstrated expertise in drafting complex commercial agreements, counseling internal clients on a range of business transactions, and coordinating internal resources;
  • Proven ability to lead negotiations and collaborate with customers – in particular pharmaceutical and medical device companies – and other counterparties;
  • Desire to work in a fast-paced startup environment and eager to get things done; and
  • Exceptional contract management skills, able to run multiple projects simultaneously.

Critical Success Factors

  • Good Judgment: Demonstrate expertise and sound judgment; provide practical, risk-balanced advice based upon a thorough understanding of the scope of an issue; and understand how assigned responsibilities support BrightInsight’s business objectives.
  • Collaboration: Understand the available legal, functional, and business resources, obtain and integrate information, and work collaboratively to achieve results.
  • Anticipation: Anticipate changes in business, operational, and legal/regulatory needs, adapt as necessary to manage risks effectively and mitigate issues before they arise.
  • Influencing Skills: Build strong relationships with business partners and customers to tactfully influence and gain their support to drive desired outcomes.
  • Initiative and Drive: Identify needs and tackle them, stay on top of projects, get things done.

Minimum Qualifications

  • Juris Doctor degree from an accredited law school, strong academic background, admitted to a U.S. state bar in good standing.
  • 6+ years of in-house legal and/or law firm experience in the pharmaceutical, medical device, medtech, or software industries.
  • Demonstrated experience advising all levels of clients on a wide variety of legal issues of interest to BrightInsight, including commercial, legal and regulatory, data privacy, intellectual property, risk management, product liability, and regulatory matters.
  • Strong commercial contracting and transactional experience.

Preferred Qualifications

  • Demonstrated understanding of the laws, regulations, standards, and guidance governing the conduct of a regulated digital health company.
  • 8+ years of combined in-house legal and law firm experience in the pharmaceutical, medical device, or medtech industries.
  • Leadership ability and pragmatic appreciation for the business consequences of legal advice; capacity to develop and articulate a clear understanding of the company’s strategy from all perspectives and find creative solutions to complex legal problems.
  • Ability to move easily between hands-on contract management and strategic thinking.
  • Ability to work cross-functionally and manage international responsibilities.
  • Ability to build collaborative relationships with leaders and co-workers at all levels.
  • Ability to travel domestically and internationally on occasion.

BrightInsight is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. BrightInsight does not discriminate in employment opportunities or practices on the basis of: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. BrightInsight provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. BrightInsight will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with BrightInsight.

 

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