Caradigm Jobs

Regulatory Affairs Director

Caradigm is a new kind of health IT company formed by GE Healthcare and Microsoft. Our goal is to transform care by empowering health systems and providers with the real-time, system-wide data and intelligence needed to improve care quality and the patient experience, and ultimately, the economics of health and wellness.

Caradigm combines the power of an open technology platform and collaborative clinical applications to bring together disparate patient data and transform it into intelligence. We enable others in the industry to take advantage of the platform to innovate—rapidly generating a new era of applications to improve population management. Our goal is to make it easy for caregivers across the entire healthcare continuum to gain the insight they need to collaborate with ease and provide the best patient care possible.

We need a leader to manage Caradigm’s commitment to worldwide medical device and healthcare IT regulations. In this role, you will work closely with product management and development teams to determine regulatory plans and secure global market authorizations for Caradigm products. This role requires a strong working knowledge of medical device laws, regulations and standards, with an emphasis on stand-alone software and healthcare IT. The position will work with a variety of Caradigm leaders, clients, vendors and regulators. The successful candidate will bring sound business judgment and strategic thinking. This is a challenging role on many fronts, requiring an individual with poise, candor, and a sincere commitment to meeting customer commitments and regulatory requirements.

Essential Responsibilities

• Establish and manage the process for medical device and classification determinations, as applied to a variety of international regulatory schemes

• Establish and manage new product regulatory plans, including government agency communications, licensing and registrations

• Research and evaluate the health risks associated with products and assure appropriate risk management practices are in place for product design and regulatory files

• Manage and/or support internal and external audits to assure medical device regulatory requirements are applied effectively across the business

• Forecast and prepare for changes to future legislation affecting Caradigm products and operations

• Represent Caradigm in client, partner and vendor discussions or negotiations involving medical device regulatory assessments and requirements

• Conduct internal training for product development teams

• Provide periodic reports on the effectiveness of the company’s regulatory management system to senior management

Basic Qualifications/Requirements

• Bachelor degree in health sciences, engineering or physical sciences. Master degree preferred

• At least 10 years of medical device regulatory planning and management experience. Experience in HC IT and data informatics preferred.

• Experience with FDA medical device 510(k) submissions and EU MDD CE marking

• Prior experience leading and managing an externally certified audit (e.g. FDA QSR or ISO13485)

• At least 5 years of experience leading, planning, and responding to internal regulatory audits

• Experience managing multiple simultaneous tactical and strategic projects using direct and virtual teams

• Demonstrated ability to communicate effectively with diverse personalities and roles within the organization. Experience in successfully representing compliance requirements to those with competing interests.

• Professional certifications such as RAC, CoRA and/or ISO 13485 lead auditor preferred

• Prior experience with health information regulations such as HITECH and HIPAA preferred

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.

This employer participates in E-Verify. The employer will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS) with information from each new employee's I-9 to confirm work authorization.