Senior Regulatory Compliance Specialist

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.

The Regulatory Affairs & Compliance Strategist sits within the Healthcare Quality System Compliance team. We are responsible for assisting the business with maintaining our 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 will be designated as an internal auditor and will have the following responsibilities:

• Prepare, perform, and report on internal audits, under the direction of the Audit Program Manager
• Assure that quality system processes and procedures comply with company policies and meet applicable regulations and standards.
• Provide support and identify improvements to the Healthcare Quality Management System (HQMS)
• Assist groups with interpretation of applicable standards and regulations as it pertains to their role and responsibilities.
• Perform audits of 3rd party suppliers, under the direction of the Audit Program Manager
• Assist the Audit Program Manager on improving and maintaining the Internal Audit program.

Additional responsibilities may include, but are not limited to identifying, researching, and driving opportunities for process and program improvements; documentation updates; assisting with external audits for the HQMS.