Job Information
Medtronic Regulatory Affairs Specialist in Fridley, Minnesota
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.
Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention, and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally, and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Provide regulatory support for currently marketed products. This includes reviewing changes to existing devices and documentation and recommending strategies for the earliest possible approval for regulatory change submissions. Prepare submissions and reports for regulatory agencies as required.
Leads or compiles all materials required for FDA Annual Reports, EU Technical Documentation updates, annual certificate submissions, and recertification submissions.
Assist team members by coordinating and preparing document packages for regulatory submissions from multiple functions for new products.
Assists team members in supporting worldwide licenses and registrations as needed.
Monitors and improves tracking/control systems.
Keeps abreast of regulatory procedures, regulatory guidance, and regulations.
May direct interaction with regulatory agencies on defined matters.
Must Have: Minimum Requirements
Bachelor's degree required
Minimum of 2 years of regulatory affairs experience
Nice to Have
Experience working in a regulated biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams.
In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Experience with Class III medical devices (PMA)
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills; MS Office, MS Project, Adobe Acrobat, and Agile
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 perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. Employees must also 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
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 (file:///C:/Users/murphe5/Downloads/Medtronic%202022%20US%20Benefits%20and%20Compensation%20Summary%20(2).pdf) .
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.
Min Salary
69600
Max Salary
104438
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.