Senior Principal Regulatory Affair Specialist at Medtronic in Minneapolis, Minnesota

Job Description:

Careers that Change Lives

Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.

A Day in the Life

The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market, provides advice on regulatory requirements, prepares submissions, and negotiates their approval. The RA Specialist also assists with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations.

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

• Directs or performs coordination and preparation of document packages for regulatory submissions from all company areas, internal audits, and inspections.
• Leads or compiles all materials required for submissions, license renewals, and annual registrations.
• Recommends labeling, manufacturing, marketing, and clinical protocol changes 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 trial applications.

Must Have: Minimum Requirements

• Bachelors degree required
• Requires a minimum of 10 years of regulatory Affairs experience, or advanced degree with a minimum of 8 years experience

• Advanced degree in a regulatory affairs.
• Experience with neuromodulation devices.
• Experience with FDA and international regulatory agency requirements, CE marking (EU MDR).
• Experience with medical devices, pharmaceuticals, or combination products (drug/biologic-device).
• Working knowledge of Medtronic procedures and systems.
• Working knowledge of Medtronic's business goals, products, therapy, customer needs, reimbursement, and competitive environment.

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.

A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans to support you at every career and life stage. Learn more about our benefits here .

In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which allows you to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here .

The provided base salary range is used nationally in the United States (except in Puerto Rico and specific CA locations).The rate offered complies with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.