In Oracle Health, we are at the intersection of healthcare and IT to deliver pioneering solutions that shape the way healthcare is provided. Our best in class technology supports clinicians and healthcare professionals in hospitals and healthcare organizations worldwide to deliver optimal patient care. We are leading the industry in using big data intelligence to enable the shift from reactive care, to proactive population level health management and are looking for a Regulatory Affairs & Compliance Strategist to join us.

 

Within our Regulatory Affairs and Compliance team, the Regulatory Affairs & Compliance Strategist is responsible for assisting the business with maintaining their ISO 9001:2015 and ISO 13485:2016 certificates and fulfilling all relevant medical device related regulatory requirements. You will be part of an international team. We are looking for someone with a strong capability to learn and with strong communication skills in a dynamic environment.

 

As a Regulatory Affairs & Compliance Strategist, you assist internal clients with the interpretation of applicable standards and regulations and the use of the Healthcare Quality Management System (HQMS). You will play key role in providing company-wide monitoring, oversight, and support for regulatory compliance and HQMS components.  You will be a subject matter expert in one or more areas of the HQMS, mentor associates on HQMS activities and processes, with the ability to influence at the team level, and you will aggregate, analyze, and communicate trends related to the HQMS to business leaders.  Additional responsibilities will include, but not limited to; identifying, researching and driving opportunities for process and program improvements as well as owning and maintaining processes around each component of the HQMS. You help coordinate and facilitate internal and/or external quality system related audits and manage the resulting actions and communications. 

 

If you’re out to change the world in ways that matter, we want to hear from you. As a member of our team, you will be joining an inclusive, social, and innovative workplace that has a strong emphasis on developing talent and promotion from within. 

 

Basic Qualifications

Bachelor's degree in Business, Management or related field, or equivalent, relevant work experience  At least 3 years of general business or health care related work experience Experience with quality management systems, ISO 9001:2015 and ISO 13485:2016

 

Preferred Qualifications

At least 3 year of information technology work experience.

 

Career Level - IC3