Principal Regulatory Affairs Specialist

MiniMed Group; California (MO); Hybrid; USD 109,000 - 185,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Health Savings Account

Life insurance

401(k) with company match

Employee Stock Purchase Plan

Job summary

MiniMed Group is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for medical devices and software, guiding submissions in the US, EU, and other regions. You will interact with regulatory agencies, shape product development pathways, and ensure compliance across lifecycle stages.

This role emphasizes collaboration with global teams, strong communication, and strategic thinking, with 100% remote work and up to 10% travel.

Qualifications

• Minimum 7 years of medical device regulatory experience with a Bachelor's degree.
• Experience with US FDA and EU MDR submissions for Class II and III devices.
• Strong negotiation and communication skills with regulatory agencies.

Responsibilities

• Develop and refine least burdensome regulatory strategies across US, EU, and global teams.
• Lead submissions and interact with regulatory authorities to secure approvals/clearances.
• Provide regulatory input to product lifecycle planning and cross-functional teams.

Skills

Regulatory affairs

Project management

Communication skills

Independent work

Education

Bachelor's degree

Tools

MS Office

MS Project

Adobe Acrobat

Job description

* You may choose to display a cookie banner on the external site. You must specify the message in the cookie banner and may add a link to a relevant policy. If you are unfamiliar with these requirements, please seek the advice of legal counsel.* .Principal Regulatory Affairs Specialist page is loaded## Principal Regulatory Affairs Specialistremote type: Remotelocations: Virtual, California, United States of Americatime type: Full timeposted on: Posted Todaytime left to apply: End Date: September 23, 2026 (6 days left to apply)job requisition id: R-801929We anticipate the application window for this opening will close on - 23 Sep 2026At 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*****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**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.#BetterDaysStartNow# **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 made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.# **Benefits & Compensation****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 - $185,000.00For 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