Sr. Manager, Product Management, Regulatory

Join us as we work to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all.

We are looking for a Senior Product Manager to join our Regulatory Product team. In this role you will be responsible for using your market and regulatory knowledge to inform and support the R&D organization, ensuring the business meets our product vision while meeting our customers’ expectations and remaining compliant.

This will require you to have a solid understanding of the US healthcare regulatory development process with specialist knowledge of Office of the National Coordinator for Health Information Technology (ONC) and Drug Enforcement Agency (DEA) Electronic Prescribing of Controlled Substances (EPCS) regulations. You will partner closely with both our Compliance and Government and Regulatory Affairs teams.

At a high level the role will include roughly even components of Product Management, Regulatory Subject Matter Expertise and Program Management.

But enough about us; let’s talk about you.

You have a passion for improving healthcare. Your drive allows you to achieve meaningful results, with empathy for the user and developer of our products and services. You can influence both horizontally and vertically inside and outside of an organization. You appreciate the software development process and the varying personalities in the cross-functional groups that we work with. You possess the ability to prioritize and multi-task in a face paced environment, manage several projects simultaneously, meet deadlines, and demonstrate sound judgement when determining whether to act independently or escalate.

You will:

• Be responsible for researching, analyzing, and interpreting applicable regulatory requirements.

• Be responsible for various compliance activities all in support of development, implementation and ongoing support of company products, programs, and initiatives.

• Be expected to exhibit sound judgment, coordination, collaboration, communication as well as technical regulatory expertise.

• Work closely with R&D stakeholders in designing, developing, and delivering new solutions.

• Support the definition of the product roadmap for delivering updates to regulatory changes by their implementation dates based on forecasted regulatory changes, conduction of business impact assessments, and weighing other business priorities.

• Understand how cross-functional R&D teams and business units work, including regulatory impacts to the products and functional areas.

• Stay up to date with the regulatory landscape to ensure our products meet the latest regulatory changes.

• Work with internal and external stakeholders to understand our clients’ regulatory priorities to inform our overall product roadmap.

• Support and develop processes to identify possible product non-conformities and liaise with regulatory bodies where appropriate.

• Design systems to promote and enforce compliance with applicable regulations and implementation of risk management policies.

• Manage, coordinate, develop, monitor, and lead regulatory programs.

Education, Experience, & Skills Required:

• Bachelor’s Degree required, Masters preferred; Degree in Healthcare, Regulatory/Government Affairs, Computer Science, or Business preferred.

• 7+ years overall professional experience, inclusive of a minimum of 2-3 years of product management experience.

• Understanding of US healthcare regulatory landscape required; direct experience with ONC, CMS and/or DEA EPCS regulations preferred.  

• Experience working directly with company Compliance and/or Government Affairs organizations preferred.

• Demonstrated success at influencing strategic vision and prioritization of products in a dynamic environment.

• Ability to explain your positioning to various people around the company in an effective way.

• Excellent verbal and written communication skills, especially with senior leaders and regulators.

Behaviors & Abilities Required:

• Ability to make good and timely decisions that keep the organization moving forward.

• Ability to focus on the desired outcomes and value for both the business and the customers when making decisions regarding execution and delivery.

• Ability to work in conjunction with product management, engineering, operations, compliance, and government affairs to raise and resolve regulatory issues.

• Ability to understand the value of and can create strong problem statements and metrics that are actionable, focused, and inspiring to achieve correct business outcomes.