Principal Regulatory Affairs Specialist

USA-MiniMed Distribution Corp. 1018; United States; Remote; USD 130,000 - 170,000; Full time

Job summary

USA-MiniMed Distribution Corp. 1018 invites you to join as Principal Regulatory Affairs Specialist, guiding medical device and software regulatory pathways across the US, EU, and international markets.

You will partner with global teams to shape submissions, navigate approvals, and ensure compliance throughout product lifecycles, with a strong emphasis on strategic planning and cross-functional collaboration.

Qualifications

• 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

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 and industry expectations to product strategies and submissions for drug delivery devices; possess broad regulatory knowledge and understanding of frameworks and processes.
• Demonstrate strong project management, writing, coordination, and execution of regulatory items with emphasis on technical and scientific activities.
• Lead negotiations and interactions with regulatory authorities during development and review processes to ensure submission approval/clearance.
• Develop and maintain relationships with regulatory agencies through communications regarding pre-submissions and submissions under review.
• Provide regulatory input to product lifecycle planning and communicate information to business teams.

Skills

Regulatory strategy

Project management

Regulatory submissions

Communication skills

Leadership/negotiation

Cross-functional collaboration

Independent work

Regulatory knowledge

Education

Bachelor's degree

Advanced degree

Tools

MS Office

MS Project

Adobe Acrobat

Job description

We anticipate the application window for this opening will close on - 30 Oct 2026

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

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. If you're energized by innovation, collaboration, and meaningful work, this is an opportunity worth exploring.

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

• 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.

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.

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 m