Regulatory Affairs Manager

🌍 Making every move matter

At Vi Centra , we’re on a mission to redefine what’s possible in diabetes care. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values;

Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.

We believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure. 🚀

As our Regulatory Affairs Manager (US), you will be the first regulatory hire in the United States, an exciting opportunity to build and own our U.S. regulatory framework from the ground up. You’ll work independently, partnering closely with our EU-based team, and become the go‑to expert for all U.S. regulatory matters.

From shaping strategy and preparing our first FDA 510(k) submission to setting up post‑market systems (complaints, vigilance, MDR), you’ll play a pivotal role in securing U.S. market access and ensuring compliance. This is a hands‑on role with a strategic edge: you’ll advise on what we need now and what’s coming next as we scale.

• 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.

• 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).

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. Here, you can shape and be shaped by groundbreaking work in Med Tech.

• Harness your talent for a mission that truly matters.

• Enjoy creative freedom, supportive teamwork, and room to lead initiatives.

• Make a direct impact in people’s lives, today and into the future.

• Be surrounded by innovators who challenge and cheer you on.

We believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.