Principal Regulatory Affairs Specialist

About the role

Help bring life-changing diabetes technologies to patients around the world. As a Principal Regulatory Affairs Specialist at MiniMed, you’ll play a pivotal role in guiding innovative medical devices and software through complex regulatory pathways, helping turn breakthrough ideas into real-world impact. Working across global teams and regulatory agencies, you’ll help shape the future of diabetes care while influencing products that improve lives every day.

Responsibilities

• Develop and refine least burdensome 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 within product development teams, quality, R&D, clinical, etc.
• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions for drug delivery devices.
• Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
• Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
• Provide regulatory input to product lifecycle planning.
• Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
• Other duties as assigned.

Position is 100% remote. Ability to travel, up to 10%, as business and local policies allow.

Requirements

Must Have: Minimum Requirements

• Minimum 7 years of medical device regulatory experience with Bachelor’s degree
• Or minimum 5 years of medical device regulatory experience with an advanced degree
• History of successful device submissions in the US and EU with both Class II and Class III devices

Nice To Have

• Medical Device Experience: Direct experience in the medical device industry, particularly with Class III/II medical devices for both FDA and EU. Experience with drug delivery hardware devices, and associated submissions, required.
• Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies. Experience with Class II and Class III device submissions in US and EU required.
• Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements, FDA and MDCG guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. Knowledge of US FDA interoperability guidance and regulations for diabetes devices desired.
• Strong Communication Skills: Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams. Prior experience as lead contact on submissions with FDA or notified bodies, including direct communication and meeting management, required.
• 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.

Benefits

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.

• Health, dental, and vision insurance
• Health Savings Account and Healthcare Flexible Spending Account
• Life insurance and long-term disability leave
• Dependent daycare spending account
• Incentive plans
• 401(k) plan with company match
• Short-term disability coverage
• Paid time off and holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• 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.

Pay

Salary ranges for U.S (excl. PR) locations (USD): $109,000 - $185,000

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location.

About MiniMed

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always-on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.