We anticipate the application window for this opening will close on - 20 Dec 2024

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**

The **Regulatory Affairs Specialist** is responsible for maintaining approval for products, developing regulatory strategies, and preparing US/EU submissions. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

**Role and Responsibilities** :

+ Maintain existing approved products.

+ Team with operating unit Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support changes to existing products.

+ Prepare regulatory (e.g., FDA/Notified Body) submissions for product changes, as required, to ensure timely approvals for market release. Review product submissions with manager and negotiate submission issues with agency personnel.

+ Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

+ Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.

+ Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

+ Ensure personal understanding of all quality policy/system items that are personally applicable.

+ Follow all work/quality procedures to ensure quality system compliance and high-quality work.

**Must Have: Minimum Requirements**

+ Bachelor’s degree required

+ Minimum of 2 years of experience in regulatory affairs in the medical device industry

+ Or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry.

**Nice to Have (Preferred Qualifications):**

+ Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).

+ Proficiency in assessing changes to labeling, design, materials and manufacturing for impact to US and EU requirements

+ RAC Certification

+ Experience with 510(k)/IDE/PMA device product submissions and EU regulations (MDR)

+ Effective interpersonal skills and team member

+ Ability to comprehend principles of engineering, physiology and medical device use

+ Ability to effectively manage multiple priorities

+ Proficient computer skills

+ Excellent oral and written skills

+ Excellent analytical thinking 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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

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.

**Welcome to our new Careers Site!**

**If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.**

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 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

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) .

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

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