Careers that Change Lives

In this dynamic role as a Senior Regulatory Affairs Specialist, you will be responsible for informing both local and global regulatory partners of sustaining changes through the Medtronic Agile system. Reporting to the Regulatory Affairs Manager, you will collaborate with various cross-functional teams, including Supplier Quality, Sourcing, R&D, Manufacturing, and Labeling, among others. Your daily activities will involve regulatory writing for internal stakeholders to efficiently document sustaining changes while ensuring comprehensive coverage. Additionally, you will coordinate with global partners on projects requiring supplementary information. This role primarily focuses on Change Management activities for sustaining Medtronic’s Diabetes products.

Our team is unique in that we can adapt to a variety of business, patient and marketplace needs that span the entire spectrum of our product portfolio today and in the future. Our mission drives the need to be a highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our patients with Type 1 and Type 2 diabetes in need of intensive insulin therapy.

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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.

A Day in the Life

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

• Coordinate and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.

• Compile materials required in submissions, license renewal and annual registrations.

• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

• Monitors and improves tracking / control systems.

• Keeps abreast of regulatory procedures and changes.

• May direct interaction with regulatory agencies on defined matters.

• Recommends strategies for earliest possible approvals of clinical trials applications.

Primary Responsibilities:

• Perform Change Management activities including hosting of meetings to acquire change details for sustaining products.

• Regulatory writings for change notifications to local/global regulatory bodies and review regulatory impact decisions of changes in relevant geographies.

• Collaborate with cross functional team to review changes and identify change scope creep to ensure change details are captured in full.

• Review/Approve qualification reports for accurate implementation, including validation plans/reports.

• Notify geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance.

• Keeps abreast of regulatory procedures and changes.

• May direct interaction with regulatory agencies on defined matters.

• Capture sustaining changes in an efficient manner to reduce overall regulatory burden while ensuring full compliance.

• Collaborate with Regulatory Operations/International teams for Product Shipment Release Authorization (PSRA) and Global Trade Identification Number (GTIN) related activities.

• Support regulatory submissions, internal/external audits and inspections, as needed.

Must Have: Minimum Requirements

• Bachelor’s degree required with a minimum of 4 years of experience in Regulatory Affairs and/or Quality/Manufacturing Engineer

• Or, advanced degree with a minimum of 2 years of Regulatory Affairs and/or Quality/Manufacturing Engineer

Nice to Have (Preferred Qualifications):

• Master’s degree

• Experience at Medtronic

• Non-conformance Material Report (NCMR) or Product Review Board (PRB) experience.

• Experience in the medical device industry/manufacturing.

• Knowledge of EU MDR and US FDA Regulations

• Medical Device Lifecycle

• Good Documentation Practice (GDP)

• ISO 13485

• Experience writing FDA annual reports

• Change Assessment

• Project Management experience

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

Min Salary

88800

Max Salary

133200

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.