Regulatory affairs Jobs in Kansas City, MO

Job Title : Senior Regulatory Affairs and Compliance Strategist

Job Location : United States

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level : Mid-Senior level

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
• At least 2 years experience with healthcare quality management systems, ISO 9001 : 2015 and ISO 13485 : 2016

Preferred Qualifications

Career Level - IC3

Responsibilities

Qualifications

Disclaimer :

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

Range and benefit information provided in this posting are specific to the stated locations only

US : Hiring Range in USD from : $70,600 - $141,200 per year. May be eligible for bonus and equity.

Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business.

Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following :

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.

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 +1 888 404 2494, option one.

Disclaimer :

Oracle is an Equal Employment Opportunity Employer

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