Sr. Regulatory Affairs Specialist- Clinical

Medtronic; Atlanta (GA); Remote; USD 92,000 - 138,000; Full time

Job summary

A global healthcare technology leader is seeking a Regulatory Affairs Specialist to develop clinical strategies for diabetes devices. This remote role requires expertise in FDA submissions and medical device regulations. Ideal candidates have a bachelor's degree and 4+ years of experience in regulatory affairs. Join a team committed to innovation and enhancing patient care while enjoying a competitive salary and comprehensive benefits package.

Benefits

Competitive Salary

Flexible Benefits Package

Short-term Incentive Plan

Qualifications

• 4+ years of regulatory affairs experience, preferably with medical device submissions.
• 2+ years of regulatory affairs experience with an advanced degree.
• Experience with FDA and EU regulatory standards.

Responsibilities

• Develop clinical regulatory strategies for diabetes devices.
• Maintain proficiency of worldwide regulatory intelligence.
• Collaborate with engineers to resolve regulatory issues.

Skills

Medical Device Experience

Regulatory Submission Expertise

Knowledge of Regulatory Requirements

Strong Communication Skills

Organizational Skills

Independence and Initiative

Computer Skills

Education

Bachelor’s degree in a scientific, healthcare, or regulatory-related field

Advanced Degree in a scientific, healthcare, or regulatory-related field

Tools

MS Office

MS Project

Adobe Acrobat

Job description

We anticipate the application window for this opening will close on - 11 Oct 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

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.

This position sits in the regulatory organization of Medtronic Diabetes and is charged with cross-functional collaboration to help build and advocate for innovative global clinical regulatory strategies for next generation diabetes devices, reimbursement, post-market surveillance activities, and expanding indications in the US, EU, and rest of world. These strategies will require a global mindset and critical thinking skills related to evolving global regulations. In this role, you will partner closely with clinical and medical affairs and work in a heavily matrixed environment consisting of functions from every aspect of the device lifecycle.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Responsibilities may include the following and other duties may be assigned.

• Develop and refine least burdensome clinical regulatory strategies to support innovations in the Diabetes business with stakeholders across the business—US, EU, international regulatory teams as well as from various partner functions such as reimbursement and R&D.

• Maintain proficiency of worldwide regulatory intelligence, including competitor filings, as part of developing innovative clinical regulatory strategies.

• Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.

• Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

• Prepare FDA, European, and rest of world clinical submissions for next-generation diabetes products and product changes that require clinical evidence (i.e. IDEs and Competent Authority)

• Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.

• Responsible for the preparation of the clinical portion of submission packages for commercialization (e.g. PMAs, 510k, Technical file dossiers, international submissions, etc.).

• Assisting with license maintenance, including annual reports, renewals, design change notifications, and QMS audits.

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

• Interact directly with FDA, Notified Bodies, and international regulatory agencies on most projects/products at the reviewer level, with significant issues reviewed with the manager.

• Other duties as assigned.

• Position is 100% remote.

• Ability to travel, up to 10%, as business and local policies allow.

To Be Successful in This Role

• Medical Device Experience: Direct experience in the medical device industry, particularly with Class III/II medical devices for both FDA and EU

• Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies.

• Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements, FDA and MDCG guidance documents, EU MDR, ISO 14971, ISO 13485, Good Clinical Practice, ICH guidelines, and other global regulatory requirements and quality standards.

• Strong Communication Skills: Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.

• Organizational Skills: Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.

• Independence and Initiative: Ability to work independently and under general direction.

• Computer Skills: Proficiency in MS Office, MS Project, and Adobe Acrobat.

Must Have: Minimum Requirements

Bachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.

OR

Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.

Nice to Have:

• 5-8 years of medical device industry experience, with at least 2-3 years in regulatory and clinical roles.

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

• Experience working in a regulated biotechnology environment, including extensive involvement with regulatory submissions and interactions with regulatory agencies.

• History of successful device submissions.

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.

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): $92,000.00 - $138,000.00

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).

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.

EEO Statement

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.