Senior Regulatory Compliance Specialist Medical Device

Job Description

Oracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care, improve operational efficiency, and enhance caregiver experiences. Building on Oracle's global expertise in cloud technology, data management, and analytics, Oracle Health delivers integrated electronic health records (EHR), population health tools, and data-driven insights for hospitals, clinics, and health systems. By connecting data and workflows across the continuum of care, Oracle Health empowers providers to make informed decisions, streamline processes, and drive better health outcomes.

The Senior Compliance Specialist provides guidance to cross-functional teams on medical device quality system compliance, with a focus on quality system support for CE marking processes and requirements under the EU Medical Device Regulation (EU MDR).

Responsibilities

The Senior Compliance Specialist will provide quality system support through conformity assessment procedures, technical documentation preparation, medical device file development and maintenance, risk management, and post-market surveillance for medical device market access. The Senior Compliance Manager coordinates and assist with both internal and external audits, including Notified Body audits related to CE marking, and helps manage corrective and preventive actions (CAPA). They assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.

The incumbent maintains up-to-date knowledge relevant regulations, works collaboratively with cross-functional teams to meet quality objectives, analyses HQMS data and metrics for management reporting, and supports supplier quality management activities.

Key Skills and Requirements

• 5 plus years of relevant experience

• BA/BS or advanced degree preferred

• Have an understanding of quality management system standards and risk management.

• Excellent written and verbal communication skills.

• Project Management Skills

• Ability to adjust and adapt to changing priorities in a dynamic environment.

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Disclaimer:

Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.

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

US: Hiring Range in USD from: $70,600 to $141,200 per annum. 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:

Medical, dental, and vision insurance, including expert medical opinion

Short term disability and long term disability

Life insurance and AD&D

Supplemental life insurance (Employee/Spouse/Child)

Health care and dependent care Flexible Spending Accounts

Pre-tax commuter and parking benefits

401(k) Savings and Investment Plan with company match

Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.

11 paid holidays

Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.

Paid parental leave

Adoption assistance

Employee Stock Purchase Plan

Financial planning and group legal

Voluntary benefits including auto, homeowner and pet insurance

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

Career Level - IC3

About Us

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

True innovation starts when everyone is empowered to contribute. That's why we're committed to growing a workforce that promotes opportunities for all with competitive benefits that 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.