Ll Oefentherapie
Senior Regulatory Compliance Specialist
Ll Oefentherapie, Washington, District of Columbia, us, 20022
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 Manager 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 Manager 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 assists 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 monitoring 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+ years of relevant experience
BA/BS or advanced degree preferred
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.
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 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.
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
Required Skills
CE Marking Process
EU Regulatory Frameworks
ISO 13485 Standards
Quality Management System
Regulatory Submissions
Support of Internal and External Audits
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.
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The Senior Compliance Manager 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 Manager 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 assists 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 monitoring 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+ years of relevant experience
BA/BS or advanced degree preferred
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.
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 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.
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
Required Skills
CE Marking Process
EU Regulatory Frameworks
ISO 13485 Standards
Quality Management System
Regulatory Submissions
Support of Internal and External Audits
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.
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