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As the Head of Digital Health and Innovation Policy, you will be a member of the Roche Diagnostic Solutions Global Regulatory Policy & Intelligence team.  You will partner with internal and external stakeholders to proactively shape regulatory environments to enhance patient access to the Roche digital health portfolio and other cutting-edge innovations in diagnostics. In this role, you serve as the primary point of contact on digital health regulatory policy and as a representative at industry organizations, coalitions, and other public forums related to digital health regulatory policy and advocacy.

The Opportunity 

You establish policy priorities consistent with our global go-to-market strategies and provide opportunities to improve time to market and reduce development costs.  This position will also lead efforts to empower others to influence the regulatory landscape affecting the availability, development, marketing and distribution of digital health solutions around the world.

You identify opportunities and challenges within the regulatory environment, establish priorities, and collaborate with key subject matter experts and stakeholders to establish DIA policy positions and advocacy plans.

You design and develop digital health and innovation regulatory policy positions to enable market access for Roche digital health solutions.

You build credibility and trusting relationships with regulators and other external stakeholders in collaboration with Quality, Regulatory, Affiliates and other influencers to make Roche a trusted partner to regulatory authorities around the world.

You act as a point of contact on digital health regulatory policy issues with the US FDA,  global regulatory agencies and other regulatory bodies, industry organizations and other advocacy  groups, supranational organizations, regions and Affiliates.

You oversee the development and maintenance of a current picture of digital health regulatory policies in individual countries  and regions. This includes providing responses (e.g., comments) to proposed digital health laws, regulations, guidance and standards submitted directly by Roche, as well as through industry organizations and coalitions.

You work with Regulatory Policy Network Leads to empower country Affiliates in advocacy efforts to influence regulatory authorities in the development and implementation of emerging digital health regulatory policies.

You leverage collaborations with other key partners within Roche Diagnostics (e.g., Government Affairs, Health Policy and Access) and Roche Group (e.g., Pharma regulatory policy) to optimize the power of OneRoche to influence regulators, governments and others who impact access to our digital health products. 

Who You Are 

You have a  B.S. in a scientific field with 10+ years of in vitro diagnostics/medical device/pharma experience or M.S. with 7+ years of in vitro diagnostics/medical device/pharma experience or Ph.D or JD with 5+ years of in vitro diagnostics/medical device/pharma experience. 

You have 3+  years experience working on medical device or pharmaceutical digital health regulatory policy initiatives.

You have strong knowledge of regulatory processes in key markets (e.g., US, EU, China) including a deep understanding of the FDA CDRH Digital Health Center of Excellence, their priorities, guidance, and their staff.

You are a subject matter expert in regulatory processes, laws and regulations, with an understanding of both the informal and formal aspects of how regulatory policy is shaped and developed.

You have demonstrated the ability to collaborate effectively and influence the diagnostic, device or drug community both internally and externally.  You have experience in negotiating successful outcomes with external agencies.

You have a proven ability to develop creative, game changing policy solutions, strategies and positions that effectively influence regulators on regulatory policy topics of interest.

Knowledge, Skills & Abilities

Strong stakeholder management, interpersonal, negotiation and presentation skills

You hold exceptional communication and advocacy skills, both written and verbal. Ability to communicate at all levels of leadership, both internally and externally. 

You can think strategically, analytically and innovatively and are able to quickly and creatively analyze situations and provide solutions to complex challenges, connecting the dots across geographies and issues. 

Locations

This can be remote with options to work out of our Indianapolis, Santa Clara, Washington DC, Branchburg, Pleasanton, Tucson, Rotkreuz, Basel, Penzberg, Mannheim, Singapore, Dubai or any other Roche affiliate locations.

Relocation benefits are available for this posting.

As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

The expected salary range for this position based on the primary location of Indiana is $145,000 $314,000.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.