Principal Regulatory Affairs Specialist at MiniMed in Virtual, California, United States of America

Job description

• 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!

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

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

Skills

Required

• Strong Communication Skills
• Organizational Skills
• Independence and Initiative
• Regulatory affairs
• FDA regulations
• EU MDR
• ISO 14971
• ISO 13485
• MS Office
• MS Project
• Adobe Acrobat

Benefits

• 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):$109,000.00 - $185,000.00
• 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. 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