REGULATORY AFFAIRS SPECIALIST - Peripheral Vascular Health (hybrid)

Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization.

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:

The Regulatory Affairs Specialist is responsible for worldwide regulatory activities to introduce new products (Class II and Class III) to market, maintain existing products and provide advice on regulatory requirements. The Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes. This role focuses on a wide variety of regulatory tasks to allow the Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set through daily activities conducted within a collaborative team environment. The Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.

The preference is for this position to be based in Plymouth, MN, Santa Rosa, CA or Galway, IR

A Day In The Life:

• Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to address questions from regulatory agencies.
• Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions.
• Maintain proficiency in worldwide regulatory requirements. Obtain and distribute updated information regarding worldwide laws, guidelines, and standards.
• Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
• Support regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
• Support product development programs as an extended core team member.
• Assist in negotiations with the FDA or other regulatory agencies for assigned projects.
• Other tasks, as assigned.

Must Have; Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field
• Minimum 2 years of experience in medical device regulatory affairs.
• Or advanced degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with no prior experience.

• Experience working with Class II/III medical devices
• Experience with regulatory support of clinical trials
• Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.
• Effective negotiation and written/oral communication skills.
• Effective interpersonal, organizational and time management skills.
• Effective and respectful team member.
• Detail-oriented

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 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 .

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

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.