Regulatory Affairs Specialist

🌍 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 a Regulatory Specialist, you will play a key role in ensuring ViCentra’s innovative medical devices meet global regulatory requirements throughout their entire lifecycle. From preparing technical documentation and supporting CE marking and FDA submissions, to interpreting new regulations and advising teams, you’ll help maintain market access and patient safety.

As the company has a scaling character, we are looking for someone who is proactive, curious, and adaptable. This is not a role where everything is pre-defined, you will need to seek out information and quickly learn new requirements as we expand into new markets.

You will work closely with cross-functional teams (manufacturing, supply chain, design, quality, clinical) to navigate complex regulatory frameworks, maintain CE marking in Europe, support submissions, and help prepare for future market entries.

• Shape and drive regulatory strategies that support product development, market approvals, and global growth, starting in the EU and US and expanding to new markets.

• Take ownership of preparing and maintaining technical documentation and submissions (e.g., CE marking, FDA 510(k)) while serving as the go-to contact with Notified Bodies and regulators.

• Stay ahead of evolving regulations (EU MDR, FDA, ISO 13485) and translate complex changes into clear, practical guidance for the business.

• Safeguard compliance of technical files, labeling, and promotional materials—balancing regulatory rigor with pragmatic solutions.

• Partner with Quality, Manufacturing, Design, and Clinical teams to navigate the regulatory impact of new products, changes, and innovations.

• Build regulatory awareness across the company by sharing knowledge, coaching colleagues, and helping teams understand what compliance means in practice.

• Infuse everything you do with boldness, customer obsession, and an unwavering commitment to excellence.

• Bachelor’s degree in Quality, Mechanical, Biomedical Engineering, Health Sciences, or equivalent experience.

• Working knowledge of medical device regulations and standards, including EU MDR 2017/745, FDA 21 CFR 820, and ISO 13485.

• Experience with risk management tools (e.g., FMEA) and regulatory/project planning.

• Strong IT skills, particularly with MS Office (advanced user of Excel, Word, PowerPoint).

• Excellent verbal and written communication skills in English.

• A self-starter mindset: proactive, curious, and able to work independently while collaborating effectively with others.

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.