Senior Regulatory Affairs and Compliance Strategist

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.

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

Responsibilities

• Ability to work overtime and irregular hours as needed.

• Work in accordance with corporate and organizational security policies and procedures, understand personal role in safeguarding corporate and client assets, and take appropriate action to prevent and report any compromises of security within scope of position.

• Perform other responsibilities as assigned.

Job duties are varied and complex utilizing independent judgment. Ability to travel. 5 plus years experience. BA/BS or advanced degree preferred. CISA, CISM, CISSP, CIPP and/or RAC, CQE, CPPS, CQA desired. Experience with IT auditing and controls, preferable with SOX, SSAE 16 - SOC 1 & SOC 2, PCI compliance, NIST, DIACAP, FedRAMP, ISO 27001 & ISO 27002 and/or ISO 9001, ISO 13485. Have an understanding of security and/or quality management system standards and risk management. Excellent written and verbal communication skills. Ability to adjust and adapt to changing priorities in a dynamic environment. Technical acumen and the ability to understand and interpret technical specifications. Technical knowledge of Oracle Applications and Database and/or infrastructure components. Project Management Skills.

About Us

As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's problems. True innovation starts with diverse perspectives and various abilities and backgrounds.

When everyone's voice is heard, we're inspired to go beyond what's been done before. It's why we're committed to expanding our inclusive workforce that promotes diverse insights and perspectives.

We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first 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 calling +~~~, option one.

Disclaimer:

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.

*** Which includes being a United States Affirmative Action Employer**