Kaleido

Regulatory Affairs Manager

Kaleido

full-time

Posted on:

Location Type: Remote

Location: Remote • New York • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • 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.
  • Bonus points for: Start-up or scale-up experience. Experience with diabetes-related products. Familiarity with risk management tools (FMEA).
Benefits
  • Working at ViCentra means joining a team defined by: Courage to create: We experiment, challenge norms, and learn fast. Trust above all: Integrity, honesty, and openness shape our relationships. Customer-first mindset: Every idea is measured by the impact on those we serve. A drive for excellence: We hold ourselves to the highest standard because lives depend on it. Our days move fast, fueled by curiosity, diverse perspectives, and a love for collaboration.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
FDA filings510(k) submissionsU.S. regulatory processesQuality Management SystemISO 13485risk management toolsFMEA
Soft skills
communication skillsproblem-solving mindsetability to work independentlycomfortable with ambiguity