Senior Regulatory Compliance Specialist

Job Description

Job Description 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. Career Level - IC3 Responsibilities 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. About Us As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. Show more Show less