Remote Principal Regulatory Affairs Lead

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

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.