Senior Manager, Global Quality Intelligence

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

This role plays a critical role in strengthening the organization’s compliance posture by integrating external regulatory insights with internal quality and audit data. This position serves as the strategic bridge between evolving global regulatory expectations and real-time internal performance signals, enabling proactive risk identification, informed decision-making, and continuous improvement. By providing clear, actionable intelligence, this position empowers cross-functional teams to stay ahead of compliance challenges, uphold regulatory standards, and protect patient safety across the product lifecycle.

 

Job Duties

• Continuously monitor and analyze global regulatory landscapes (e.g., FDA, EMEA, MHRA, MDSAP, etc.) for emerging issues, guidance updates, enforcement actions, and best practices relevant to medical devices.
• Partner with internal audit, quality, regulatory, operations teams, and notified bodies to identify recurring findings, trends, or signals from audits, inspections, CAPAs, and quality metrics.
• Use data analytics to assess potential impact and likelihood of compliance risks, helping prioritize mitigations and resource allocation accordingly and present to senior management.
• Provide real-time support during local hours for global audits/inspections; may include working in the Global Inspection Center or on-site support.
• Collaborate with product teams, regulatory affairs, quality assurance, and risk management to ensure alignment and a unified approach to proactive compliance.
• Provide early warning and strategic guidance on potential regulatory shifts that may affect product lifecycle, market access, or post-market surveillance obligations.
• Develop and deliver internal briefings and training to raise awareness of emerging regulatory expectations and lessons learned from audit outcomes.
• Deliver recommendations based on compliance and patient risk.
• Identify issues that require prompt notification and present/communicate to leadership in a clear and concise manner.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develop and implement new approaches to solve problems identified as part of cross-functional teams, audit findings, and regulatory information and trends.
• Perform other duties and projects as assigned.

Job Qualifications

Required:

• Bachelor’s degree in a science, engineering discipline, regulatory affairs, medical device regulation, change management or equivalent.
• Minimum of 10 years of related experience in a medical device, pharma, or other regulated industry.
• Minimum of 10 years directly communicating with and managing correspondence to worldwide Regulatory agencies.
• Experience with business intelligence tools and techniques.
• Minimum of 5 years of experience managing teams.
• Expert knowledge in medical device regulations, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
• Extensive experience working with inspection/audit management, CAPA systems, and medical device quality systems.
• Demonstrated ability to analyze and synthesize data from multiple sources to develop strategic insights. 
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
• Program management experience managing multiple programs and projects to meet deadlines.