Senior Compliance Manager

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.

Basic Qualifications

• 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

Preferred Qualifications

• 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

The successful candidate will contribute to maintaining and improving quality and compliance programs, supporting audits and inspections, managing change control processes, and helping ensure adherence to healthcare and life sciences regulatory standards. This includes:

• Administer and support the Oracle Health & Life Sciences change management program, including managing change requests and coordinating Change Advisory Board (CAB) meetings.
• Coordinate and facilitate external audits and regulatory agency inspections, including follow-up activities and documentation management.
• Participate in and manage projects related to quality management systems and regulatory compliance initiatives.
• Author, review, and maintain quality management system policies, procedures, and related documentation.
• Prepare and provide compliance and change management metrics for management review activities.
• Host and facilitate recurring departmental status meetings and cross-functional discussions.
• Collaborate with global stakeholders across multiple time zones to support compliance objectives and operational excellence.
• Support continuous improvement initiatives within healthcare and life sciences quality systems.
• Assist in ensuring compliance with applicable regulatory standards and frameworks, including healthcare and life sciences requirements.

Career Level - IC3