We anticipate the application window for this opening will close on - 4 Sep 2026

About the Role

This position sits in the regulatory organization of MiniMed 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.

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

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor's degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.

Nice to Have:

• 5-8 years of 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.

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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

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the base salary range is $97,000 to $165,000 annually.

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview