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Kaleido · 1 month ago

Regulatory Affairs Manager (US)

United States

Full-time

Remote

Mid, Senior Level

ViCentra is on a mission to redefine diabetes care through technological innovation and human-centered design. As the Regulatory Affairs Manager (US), you will build and own the U.S. regulatory framework, preparing FDA submissions and ensuring compliance for market access.

Health CareMedicalMedical Device

Growth Opportunities

Responsibilities

Develop and execute U.S. regulatory strategies to support product clearance and lifecycle management

Prepare, submit, and maintain FDA filings (e.g., 510(k), device listings, establishment registration)

Act as primary liaison with the FDA, including participation in meetings and responding to questions post-submission

Set up and manage U.S. post-market systems: complaints, vigilance, MDR, recalls, and surveillance

Integrate regulatory requirements into our Quality Management System (Egnyte/ETQ)

Monitor evolving FDA regulations and translate them into actionable guidance

Collaborate with cross-functional teams (Quality, Engineering, Clinical) to ensure compliance and readiness for scale

Qualification

U.S. medical device regulations510(k) submissionsRegulatory strategy developmentQuality Management SystemRisk management toolsStart-up experienceDiabetes-related productsCommunicationProblem-solving mindset

Required

Bachelor's degree in Quality, Biomedical Engineering, Health Sciences, or related field

Solid knowledge of U.S. medical device regulations (FDA 21 CFR Parts 803, 807, 820) and ISO 13485

Hands-on experience with 510(k) submissions and U.S. regulatory processes

Ability to work independently in a fast-moving, scale-up environment—comfortable with ambiguity and building from scratch

Excellent communication skills and a proactive, problem-solving mindset

Preferred

Start-up or scale-up experience

Experience with diabetes-related products

Familiarity with risk management tools (FMEA)

Company

Kaleido

ViCentra BV, Medical Devices, Utrecht Founded in 2013 in Utrecht, The Netherlands, ViCentra is a leading early stage commercial company focused on the development, manufacturing and commercialisation of the Kaleido insulin pump designed to help people with diabetes live life on their own terms.

Founded in 2013