Principal Regulatory Affairs Specialist

MiniMed•Virtual, CA

6d•$109,000 - $185,000•Remote

About The Position

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. Ready to make an impact? Apply now and join our team!

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
Prior experience as lead contact on submissions with FDA or notified bodies, including direct communication and meeting management, required.
Proficiency in MS Office, MS Project, and Adobe Acrobat.

Nice To Haves

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.
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.
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.
Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
Ability to work independently and under general direction.

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.