Senior Manager, Global Quality Intelligence

Olympus Corporation of the Americas; Center Valley (Lehigh County); Remote; USD 117,000 - 164,000; Full time

Job summary

Olympus Corporation of the Americas is seeking an experienced compliance strategist to strengthen their organizational compliance posture. This role involves collaborating with various teams for proactive compliance while delivering actionable intelligence on regulatory expectations, ensuring patient safety, and influencing cross-functional strategies.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance

12 Paid Holidays

On-Site Child Daycare

Qualifications

• 10+ years of experience in a medical device or regulated industry.
• Expert knowledge in medical device regulations like FDA and ISO 13485.
• Experience managing teams.

Responsibilities

• Monitor and analyze global regulatory landscapes for compliance.
• Collaborate with internal teams for quality and regulatory alignment.
• Develop training on emerging regulatory expectations.

Skills

Analytical skills

Problem solving

Interpersonal skills

Leadership

Collaboration

Education

Bachelor’s degree in a science or engineering discipline

Tools

Business intelligence tools

Compliance intelligence tools

Power BI

Tableau

Job description

Working Location:NATIONWIDE

Workplace Flexibility:Field

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

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

Our fiveCore Valuesempower 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.
• Fluent in English language and specific skills such as computer skills, mathematical skills are required.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Travel up to 25% (international) may be required.

Preferred:

• Having prior FDA experience leading the front room and back room would be a plus.
• Proficiency with compliance intelligence tools, dashboards (e.g., Power BI, Tableau), or regulatory tracking systems is a plus.
• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (Quality, Manufacturing, Regulatory, Risk, etc.).
• Proven leadership, teamwork, collaboration and influencing skills.
• Strong problem solving and strategic thinking.
• Ability to work effectively and with agility in a fast paced and dynamic environment.
• Strong knowledge in medical device regulatory requirements and Quality Management System.
• Proven ability to influence cross-functional teams and senior leadership.
• Strong analytical mindset with a systems-thinking approach.
• Ability to collaborate, develop strong working relationships, and demonstrate leadership and project management capabilities within a matrixed organization environment.
• Impeccable organizational skills, critical thinking, solutions-oriented, attention to detail.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is$117,068.00-$163,896.00/ year, plus potential for annual bonus (subject to plan eligibility and other requirements).Olympus considers a variety of factors when determining actual compensation for this positionincluding: level of experience, working location, and relevanteducation and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||Quality & Regulatory Affairs (QA/RA)