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Pre-Market Product Security Governance

3 months ago


Valley Center, Kansas, United States Olympus Corporation of the Americas Full time

Working Location: PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Hybrid

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 of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus ) .

**Please note: All correspondence will be sent from our Olympus domain ). If you receive correspondence from an entity other than , it is likely not legitimate.

Job Description

In this role you will be responsible for ensuring the security and compliance of our products before they are released to market by assisting in the development, implementation, and training of pre-market product security policies, standards, and guidelines. You will help manage global cross functional governance of cybersecurity pre-market activities in your local region, working across various stakeholders such as Research and Development, Quality, and Regulatory Assurance. In this role you are expected to have a strong background in cybersecurity, risk management, regulatory compliance and software development frameworks.

Job Duties

  • Assist in the development, implementation, and maintenance of security policies, standards, and guidelines for product development teams.
  • Ensure security policies are aligned with industry best practices and regulatory requirements – both current and evolving.
  • Assure Olympus's products are fully compliant to regional product security related regulations prior to submission.
  • Educate and train team members on advanced product security related knowledge and skills.
  • Work closely with cross-functional teams, including R&D, Quality, and Regulatory.
  • Align with the level of Director, or VP of product security related functions.
  • Define the basic requirements for secure development within regional R&D teams, as defined by the global Product Security Pre-Market Governance team.
  • Provide expert assistance and recommendations when visualizing risks and with risk remediation / mitigation plans for associate products.
  • Communicate security requirements and best practices to internal and external stakeholders.
  • Other Considerations (travel/hours availability, etc.): Ability to travel 10-15% and accommodate occasional out-of-hours meetings due to operating in a global organization.

Job Qualifications

Required:

  • Bachelor's degree (or equivalent) required with a specialization in Information Security, or Computer/Software Engineering, or related field.
  • Minimum of 5 - 7 years demonstrable experience in addressing product security risks (e.g., threat modelling, risk assessment activities, trust boundary analysis, component analysis, testing), experience in software development (in Medical Device industry preferrable), including security tools and technologies used in product development.

Preferred:

  • Relevant certifications such as CISSP, CISM, CISA, or similar are highly desirable.
  • Experience in developing, operating, and maintaining product security programs and controls (Medical Device organization preferrable)
  • Proven experience in risk management and/or regulatory compliance.
  • Skills in software development project management (preferrable)
  • Demonstrated understanding of state of art security requirements/regulations/flameworks/guidance including, but not limited to: FDA (preferrable), IMDRF, NIST, IEC
  • Knowledge of application development in a Secure Software Development Lifecycle
  • Knowledge of security diagnosis, security testing (static/dynamic, pen-testing, etc.).
  • Functional knowledge of core product security functions including strategy, operations, assessments, incident response, investigations, compliance.

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
  • Diversity Equity & Inclusion Initiatives including 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 ) .

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 .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

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.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Information Technology (IT)