We anticipate the application window for this opening will close on - 11 Jun 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

A Day in the Life

Enabling Technologies - Together with our customers, we are moving spine and cranial surgery from an art to a science.

By integrating advanced technologies and a patient-centric approach, we can drive improvements in outcomes, efficiency, and overall well-being for millions of people around the world.

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

In this exciting role as the Sr. Principal Product Steward, you will partner closely with Product Development, Quality, Regulatory and Manufacturing as a pro-active problem solver to help identify, document, mitigate and/or resolve issues while ensuring compliance with Regulatory requirements. You will work within a team environment.

The Product Steward is responsible for assessing the applicable regulations for device compliance with current and ongoing Global Product & Environmental requirements, including EU MDR, RoHS, REACH, WEEE, Prop-65, etc.

Responsibilities may include the following and other duties may be assigned.

• Deep understanding of Materials/substances of Concern (MOC) in medical device regulations (EU MDR, CFR 820), requirements set by regulatory bodies (FDA, EU notified bodies etc.), and international standards.

• Provide chemical safety expertise to various regulatory compliance teams

• Independently determines task and steps related to MOC/medical device regulations applied to various products. Plays an integral role in the strategy and tactical operations of the applicable regulations. Collaborate with cross-functional team to manage the broad range of compliance with regulations for various products.

• Guides and performs analytical testing for qualitative/quantitative characterization of extractable, leachable, and degradation products, in support of product development and sustaining commercial products.

• Applies a broad range of knowledge in analytical technologies (e.g., FTIR, ICP/MS, GC/MS, LC/MS).

• Educates internal/external teams in Materials of Concern compliance and testing. Demonstrates strong written/verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions

• Create technical reviews and other mandatory documents for regulatory submissions

• Update department technical procedures, work instructions, and other documentation as required

• Be professional, concise, and sensitive in accomplishing objectives. Be able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable 

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Requires a Baccalaureate degree in a technically related field

• Minimum of 10 years of relevant experience

• OR advanced degree with a minimum of 8 years of relevant experience.

Nice to Have 

• Deep subject matter knowledge and application of the ISO 10993-1 series of biocompatibility standards 

• Advanced Knowledge of Global MOC Regulations: Expertise in navigating the complexities of Materials/Substances of Concern (MOC) regulations across multiple regions, including EU MDR, CFR 820, REACH, and other international standards.

• Proven ability to provide strategic chemical safety guidance to regulatory compliance teams, ensuring alignment with FDA, EU Notified Bodies, and other global regulatory requirements.

• Demonstrated success in leading cross-functional teams to implement robust compliance strategies for MOC across diverse product portfolios.

• Extensive experience conducting and interpreting qualitative and quantitative analyses of extractable, leachable, and degradation products using advanced analytical techniques such as FTIR, ICP/MS, GC/MS, and LC/MS.

• Strong track record of optimizing testin