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Head of Regulatory Policy, Google Health

Company: Google Inc.
Location: Palo Alto
Posted on: May 3, 2021

Job Description:

Minimum qualifications:

* Bachelor's degree or equivalent practical experience. * 10 years of experience in regulatory policy and/or affairs. * Experience with US/FDA medical device regulation, patients, science and public health. * Experience leading regulatory policy initiatives.

Preferred qualifications:

* Experience working for a government health agency. * Experience with SaMD/hardware, digital health product regulation and regulatory policy/intelligence. * Demonstrated ability interpreting and analyzing regulation, guidance, and regulatory review documents. * Ability to work effectively as part of a global organization with internal leaders/subject-matter-experts and external stakeholders (e.g., government officials and trade-association executives).

About the job

As the Head of Regulatory Policy, you will be responsible for coordination and support of Google Health's regulatory policy agenda. In this role, you will play a key role in strategic planning, coalition development, and regulatory policy analysis in furtherance of Google Health related regulatory policy goals, as well as the Public Engagement strategy of Trust program. You'll support our patient-focused medical device/Software as a medical device (SaMD) and consumer product regulatory policy issues/ trends/ changes occurring in the medical device/SaMD regulated environment that have the potential to impact our products and ensure that product strategies are adapted accordingly in order to enhance the product's probability of success.

You will work closely with several cross-functional areas (e.g., Regulatory Affairs, Quality, Clinical Safety/Risk Management, Health Privacy/Information Governance, Bioethics, Operations and Program Management), as well as other partner functions such as Government Affairs/Public Policy (GAAP), Engineering, Clinical, Communications, Marketing, Legal, Research, etc., to contribute to development and execution of Google Health's regulatory policy agenda.

Google Health has made major advances in healthcare research, such as detecting eye disease more quickly and accurately than experts, planning cancer radiotherapy treatment in seconds rather than hours, and working to detect patient deterioration before it happens with electronic records.

Fundamental research is at the core of Google Health - the multidisciplinary team collaborates with partners to publish novel research in renowned scientific journals. They then work to apply this research into the medical field, whether through Streams, our clinical assistant app, or other clinical hardware and products developed in Google. Working alongside colleagues across Google, you'll help make this vision a reality.

Responsibilities

* Perform research into relevant regulations, regulatory precedent, and other asset-specific research projects to support our products and development pipeline. * Drive regulatory outreach and advocacy effort. * Collaborate with FDA, EMA and other government officials to lead strategic regulatory policy initiatives for digital health/SaMD products in regards to the use of AI, Machine Learning, etc., which could include providing input on new legislation, guidances, etc. * Managing department-related tasks/support to ensure timely execution, cross-functional collaboration and streamlined facilitation. * Facilitate Regulatory Policy related operations for the Quality, Regulatory, Safety and Trust (QRST) leadership team as they work to maintain relationships with government officials, relevant community leaders, advocacy groups, external organizations, patients and stakeholders.

Keywords: Google Inc., Palo Alto , Head of Regulatory Policy, Google Health, Other , Palo Alto, California

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