Sr. Principal Product Steward
Job Description
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 testing methodologies to improve efficiency and accuracy in the characterization of materials for regulatory compliance.
Ability to independently develop and execute strategic plans for addressing MOC regulatory compliance challenges, ensuring timely and effective product support.
Experience performing toxicological risk assessments for materials, extractables, and leachables to support regulatory submissions.
Exceptional written and verbal communication skills, with a proven ability to present complex scientific and regulatory information to diverse audiences, including regulatory bodies and internal stakeholders.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Company Information
Location: Dublin, Ireland
Type: Hybrid