Introduction

At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most challenging problems? If so, lets talk.

Your Role and Responsibilities

• Provide quality/regulatory support for AI and digital health technology development programs for new and existing products in accordance with the Quality Management System
• Work cross-functionally with the business and marketing leaders, the solution teams, regulatory, legal and other stakeholders to assist in maintaining compliance for the products
• Under supervision, prepares and submits regulatory applications, as well as internal quality and regulatory file documentation to achieve market clearances in US, Canada, EU, Australia, Japan, Singapore and Brazil as applicable
• Reviews and signs-off on product changes including manufacturing changes for compliance with applicable regulations and guidances in US, Canada, EU, Brazil, Japan, Singapore and Australia
• Initiates quality assurance activities such as corrective actions, product investigations and holds, as needed
• Participate in audits and inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations
• Perform Regulatory and Quality Intelligence activities to ensure intel is current amidst changing regulations and standards
• Contribute to the development of quality and regulatory department policy and procedure implementation

Required Technical and Professional Expertise

• BA/BS in a scientific discipline
• Fundamental understanding of quality assurance standards and medical device regulations in accordance with USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore requirements
• Excellent interpersonal, communication, and negotiation skills

Preferred Technical and Professional Expertise

• Completed a BA/BS degree in a scientific or technical discipline required; completion of an advanced regulatory or quality degree preferred
• Experience in healthcare medical device or life sciences pharmaceutical experience preferred
• Course work in engineering, software or global regulatory submission requirements for medical devices; software medical devices preferred
• General understanding of product development process and design control

About Business Unit

IBM's Cloud and Cognitive software business is committed to bringing the power of IBM's Cloud and Watson/AI technologies to life for our clients and ecosystem partners around the world. IBM provides you with the most comprehensive and consistent approach to development, security and operations across hybrid environments—with complete software solutions for business and IT operations, development, data science, security, and management. Our experts and software capabilities help organizations develop applications once and deploy them anywhere, integrate security across the breadth of their IT estate, and automate operations with management visibility. With IBM, you also have access to new skills and methods, governance and management approaches, and a deep ecosystem of industry experts and partners.

Your Life @ IBM

What matters to you when you're looking for your next career challenge?

Maybe you want to get involved in work that really changes the world? What about somewhere with incredible and diverse career and development opportunities - where you can truly discover your passion? Are you looking for a culture of openness, collaboration and trust - where everyone has a voice? What about all of these? If so, then IBM could be your next career challenge. Join us, not to do something better, but to attempt things you never thought possible. Impact. Inclusion. Infinite Experiences. Do your best work ever.

About IBM

IBM's greatest invention is the IBMer. We believe that progress is made through progressive thinking, progressive leadership, progressive policy and progressive action. IBMers believe that the application of intelligence, reason and science can improve business, society and the human condition. Restlessly reinventing since 1911, we are the largest technology and consulting employer in the world, with more than 380,000 IBMers serving clients in 170 countries.

Location Statement

IBM will not be providing visa sponsorship for this position now or in the future. Therefore, in order to be considered for this position, you must have the ability to work without a need for current or future visa sponsorship.

We consider qualified applicants with criminal histories, consistent with applicable law. IBM intends this job to be performed entirely outside of Colorado.

Being You @ IBM

IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

IBM’s greatest invention is the IBMer. We believe that through the application of intelligence, reason and science, we can improve business, society and the human condition, bringing the power of an open hybrid cloud and AI strategy to life for our clients and partners around the world.

Restlessly reinventing since 1911, we are not only one of the largest corporate organizations in the world, we’re also one of the biggest technology and consulting employers, with many of the Fortune 50 companies relying on the IBM Cloud to run their business.

At IBM, we pride ourselves on being an early adopter of artificial intelligence, quantum computing and blockchain. Now it’s time for you to join us on our journey to being a responsible technology innovator and a force for good in the world.