Regulatory Affairs Manager

November 25

🗽 New York – Remote

Although this job is listed in New York, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Kaleido

WebsiteLinkedInAll Job Openings

Hardware • SaaS • Artificial Intelligence

Kaleido is a medical device company offering a reusable, wearable insulin patch pump and a modular hybrid closed‑loop diabetes management system. Kaleido’s compact, water‑resistant pump can be worn as a patch or carried in a pocket and integrates with Diabeloop’s DBLG1 algorithm and the Dexcom G6 continuous glucose monitor to automate and personalize insulin delivery using a self‑learning algorithm. The system includes cloud-based data access (YourLoops) for users and healthcare professionals, is CE‑marked for adults, and aims to increase time‑in‑range and day-to-day freedom for people with type 1 diabetes.

51 - 200 employees

Founded 2013

🔧 Hardware

☁️ SaaS

🤖 Artificial Intelligence

📋 Description

• 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.