Senior Regulatory Affairs Specialist - Supplier Transfer Optimization Program (US Remote)

The person in this role may work remotely within the US or onsite at a US-based Medtronic facility.

CAREERS THAT CHANGE LIVES

The strategic intent of the newly designed Global Operations and Supply Chain (GO&SC) Operating Unit is to create a more agile and responsive manufacturing and supply chain organization. One that anticipates and meets the needs of our customers, our patients, and our stockholders - effectively becoming a competitive advantage for Medtronic. Leading the way is the Supplier Transfer Optimization Program (STOP), an initiative aimed at reducing the number of vendors in our direct materials supply base to significantly optimize our supply base.

As a Senior Regulatory Affair Specialist supporting STOP, you will plan and execute regulatory strategy for supplier transfer projects. You'll assess the regulatory impact of supplier transfers and lead project teams through the regulatory requirements. In this role, you will be a member of the Medtronic Clinical and Regulatory Solutions (MCRS) organization.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career that changes lives. Medtronic is committed to fostering a diverse and inclusive culture.

A DAY IN THE LIFE

• Act as Regulatory Affairs representative on project transfer teams.

• Plan and execute regulatory strategy for supplier transfer projects.

• Perform regulatory assessment for supplier transfers.

• Create and manage materials required to support project deliverables.

• Monitor and maintain compliance with multiple Quality Management Systems.

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

MUST HAVE (Minimum Qualifications)

• Bachelor's degree
• 4+ years of experience with a bachelor's degree or 2+ years of experience with an advanced degree

NICE TO HAVE (Preferred Qualifications)

• 4+ years of regulatory affairs experience strongly preferred

• 4+ years of experience in medical device regulatory affairs with roles showing increasing responsibility.

• US and global regulatory affairs knowledge and experience.

• Advanced degree in engineering or regulatory affairs.

• Microsoft Word, Excel, and Adobe software skills.

• Experience working with cross-functional teams.

• Experience working with technical documentation/STED.

• Effective verbal and written communication skills both internally and externally.

• Experience with solving problems and concerns.

• Experience with project management and adherence to time schedules.

• Work well under pressure in a dynamic environment.

• Highly organized, detail-oriented, and efficient.

• Team player who seeks to help and learn from colleagues seeing the department success as their own

• Ability to manage projects to completion within and outside of the direct department and company.

• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

• Proactively seeks to develop and become well-versed within the regulatory landscape.

• RAPS Regulatory Affairs Certification (RAC).

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.

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 at http://benefits.medtronic.com.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

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

EEO STATEMENT

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.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.