Senior Regulatory Counsel

OpenLoop Health

5d•Remote

About The Position

OpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring care anywhere. Our telehealth support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states. OpenLoop is looking for a Senior Regulatory Counsel to join our team remotely or at HQ in Des Moines, IA. In this role, you will be responsible for serving as a trusted advisor to leadership and cross-functional teams, providing strategic legal counsel on a wide array of healthcare regulatory matters. This role is ideal for a seasoned healthcare regulatory lawyer who thrives in a fast-paced, innovative environment and is passionate about navigating complex legal frameworks impacting telehealth, digital health, and pharmacy operations.

Requirements

Juris Doctor (JD) from an ABA-accredited law school and active license to practice law in at least one U.S. jurisdiction.
8+ years of healthcare regulatory experience, ideally including both telehealth and pharmacy operations.
Deep understanding of healthcare laws and regulations, including telehealth compliance, FDA regulatory matters, compounding, and state-by-state professional practice standards.
Demonstrated ability to interpret and advise on complex regulatory issues across care delivery, digital health, and pharmacy operations.
Proven track record of providing strategic, business-oriented legal counsel in a fast-moving environment.
Strong communication and collaboration skills, with the ability to influence and partner effectively across multidisciplinary teams.
Exceptional organizational, analytical, and project management skills with the ability to prioritize multiple initiatives.
Positive, proactive, and adaptable mindset, with a passion for improving access to healthcare through innovative solutions.

Nice To Haves

Experience engaging with regulatory and licensing authorities such as the FDA, Boards of Medicine, or Boards of Pharmacy preferred.

Responsibilities

Serve as a key legal advisor supporting multiple business units, including care operations, medical affairs, pharmacy, product development, and policy teams, ensuring compliance with all applicable healthcare laws and regulations.
Provide practical, solution-oriented advice on telehealth, digital health, and pharmacy compliance, including issues related to the Corporate Practice of Medicine (CPOM), provider licensing, credentialing, prescribing, and scope of practice.
Counsel internal teams on federal and state healthcare regulatory frameworks, including FDA regulations, telehealth modalities, privacy (HIPAA), compounding, and professional practice standards.
Support the growth and product counsel teams on regulatory aspects of new product and service launches.
Partner with the public policy team to assess, interpret, and shape proposed laws, rules, and regulations affecting healthcare and pharmacy operations.
Proactively identify and mitigate legal risks related to healthcare operations, pharmacy services, and emerging digital health technologies.
Stay current on evolving state and federal healthcare laws, including developments from the FDA, Boards of Medicine, Boards of Pharmacy, and other regulatory bodies.
Collaborate with internal stakeholders to develop and maintain policies, procedures, and best practices that align with regulatory standards.
Other duties as assigned.