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At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Peripheral Vascular Health is dedicated to the treatment of peripheral arterial and venous diseases. We offer our physician customers a comprehensive suite of products and therapies to treat varying degrees of vascular disease — disorders of the circulatory system outside of the brain and heart. Our goal is to help healthcare professionals save limbs, reduce pain, and treat disease — so their patients can get back to enjoying what they love.

The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for Class II and Class III medical devices including combination products. The Regulatory Affairs Specialist is responsible for activities that lead to, and maintain regulatory approval for these medical devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implanting these device changes. This position typically reports to the Regulatory Affairs Manager.

Role and Responsibilities

• Prepare or assist in global regulatory submissions such as original IDE, original PMA and 510(k) submissions and supplements, EU Design Dossiers and Technical Files, Competent Authority Consultation Packages, Canadian Device License Applications, and Japanese Shonins.

• Monitor emerging regulatory trends and integrate new requirements into department procedures and toolkits.

• Provide regulatory support to currently marketed products, as necessary. Assesses product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.

• Provide regulatory support to product manufacturing transfers. Provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes. Provide statistical support and bridging between Clinical and Data Management/Biostatistics team members. Implement regulatory aspects of Field Actions

• Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis. Provide regulatory input to the company for compliance with ISO, Japan, and FDA Quality System Regulation requirements.

• Provide input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP), as well as to ensure efficient and approvable study designs

• Assist in negotiations with the FDA or other regulatory agencies for assigned projects.

• Obtain and distribute updated information regarding worldwide laws, guidelines, and standards. Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities.

• Develop and deliver presentations to worldwide regulatory agencies. Topics may include submission strategies, technical and statistical approaches, compliance issues or new initiatives. Assist in developing and maintaining positive relationships with device reviewers through oral and written communications.

• Other tasks, as assigned.

Must Have; Minimum Requirement

• Bachelor's Degree with a minimum of 2 years regulatory affairs, quality or engineering

• Or an advanced degree with 0 years of experience

Nice To Have

• History of successful 510(k)/IDE/PMA device/combination product submissions and other worldwide submissions and clearances

• Experience with regulatory support of clinical trials.

• Previous experience supporting manufacturing and design changes

• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

• Previous experience with document management systems and change control systems.

• Strong negotiation skills and written/oral communication skills

• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines

• Strong organizational skills and time management skills

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

Salary ranges for U.S (excl. PR) locations (USD):$69,600.00 - $104,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.

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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

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