Regulatory Affairs Specialist - Post Market

Medtronic; Minneapolis (MN); On-site; USD 73,000 - 111,000; Full time

Job summary

A leading company in medical technology seeks a Regulatory Affairs Specialist to develop regulatory strategies and maintain product approvals. The role involves collaboration with engineering teams and managing regulatory submissions while ensuring compliance with global standards. We are committed to innovation and healthcare equity, offering a vibrant workplace that values diverse perspectives.

Benefits

Health, Dental and Vision insurance

Tuition assistance/reimbursement

401(k) plan with employer contribution

Employee Stock Purchase Plan

Paid time off and holidays

Life insurance and long-term disability leave

Qualifications

• Bachelor's degree required with a minimum of 2 years of experience in regulatory affairs in the medical device industry.
• Experience with Class II/III medical devices is preferred.
• Experience with FDA requirements and global regulatory standards.

Responsibilities

• Develop regulatory strategies and prepare U.S. and global submissions.
• Collaborate with regulatory affairs specialists and technical experts.
• Support product development programs as a core team member.

Skills

Effective negotiation

Written communication skills

Oral communication skills

Effective interpersonal skills

Organizational skills

Time management skills

Detail-oriented

Education

Bachelor's degree

Advanced degree

Job description

We anticipate the application window for this opening will close on - 10 Jun 2025

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

TheRegulatory Affairs Specialistis responsible for developing regulatory strategies, preparing U.S. and global submissions, and obtaining and maintaining approval for CRM products globally.Additionally, the Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

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.To learn more about Inclusion & Diversity at MedtronicClick Here

Location: Mounds View, MN

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

A Day in the Life/ Responsibilities:

• Collaborate with Operating Unit Regulatory Affairs Specialists and regulatory affairs specialists globally 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 required with a minimum of 2years of experience in regulatory affairs in the medical device industry

Or

• Advanced degree with0years of experience

Nice to Have (Preferred Qualifications):

• 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

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 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. (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 at benefits.medtronic.com

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):$73,600.00 - $110,400.00 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

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 95,000+ 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.

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.