Senior Compliance Manager

Oracle•United States,

7d•$70,600 - $141,200

About The Position

Join Oracle Health & Life Sciences as a Regulatory Compliance Manager supporting global quality and compliance initiatives. Help drive change management, audit readiness, and quality system excellence in a fast-paced, highly regulated healthcare environment. Will support the Health Compliance Organization (HCO) in a broad range of compliance and quality management system activities. This role is ideal for a detail-oriented professional with experience in regulated industries, strong organizational and project management skills, and the ability to collaborate across international teams and time zones.

Requirements

5+ years of experience in compliance, quality management, regulatory affairs, or related functions
Experience supporting compliance programs in healthcare, life sciences, medical device, pharmaceutical, or technology environments
Demonstrated experience coordinating audits, inspections, or regulatory assessments
Experience managing documentation and change control processes
Strong interpersonal and stakeholder management skills
Ability to work effectively across international teams and multiple time zones
Ability to travel up to about 10% of the time

Nice To Haves

Knowledge of quality management systems (QMS) and regulatory compliance frameworks, such as EU Medical Device Regulation, ISO 9001, ISO 42001, ISO 13485, HIPAA/HITECH, and/or MDSAP
Knowledge of change management processes
Strong project management and organizational skills
Experience authoring and maintaining policies, procedures, and compliance documentation
Ability to analyze and present compliance metrics and reports
Strong verbal and written communication skills
Ability to facilitate meetings and collaborate across cross-functional global teams
Experience working with continuous improvement initiatives
Ability to manage multiple priorities in a fast-paced environment
Detail-oriented with strong problem-solving and analytical skills
Proficiency with Microsoft Office and compliance/document management tools
Bachelor’s degree in a related field such as healthcare, life sciences, quality, regulatory affairs, or business administration
Relevant certifications (preferred but not required), such as: Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Regulatory Affairs Certification (RAC), ITIL or change management certifications

Responsibilities

Support global quality and compliance initiatives.
Drive change management, audit readiness, and quality system excellence.
Support the Health Compliance Organization (HCO) in a broad range of compliance and quality management system activities.