Job Description

VARDIS is a Swiss-based oral health company founded by Dr. Haleh and Dr. Golnar Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative vision of its founders.

At vVARDIS, we are committed to delivering innovative solutions that enhance oral health and well-being, inspired by the vision of our founders to foster preventive rather than reparative dentistry. At the heart of our Company lies its patented, revolutionary biomimetic peptide technology. Scientifically proven in over 200 publications, this unique technology can treat early caries through enamel regeneration, like no other technology can do, offering a non-invasive, pain-free solution for patients of all ages. We offer a number of oral health products targeting dental professionals and their patients, as well as consumers, all based on our proprietary technology.

We value our people and believe in fostering a positive and collaborative work environment, based on our core values of innovation, excellence, integrity, and empathy.

We are seeking a dynamic and experienced Quality Assurance and Regulatory Affairs Director to lead and oversee Quality and Regulatory activities for our diverse product portfolio, including medical devices, pharmaceuticals (drugs), and cosmetics. This is a key leadership role that requires an all-rounder with deep expertise in quality management systems (QMS), regulatory compliance, supplier management, and product lifecycle oversight. The role is based in the U.S., preferably on the East Coast, and reports directly to the Head of Quality & Regulatory Affairs in Switzerland.

As part of a global healthcare organization, you will play a strategic role in maintaining compliance, managing regulatory submissions, and driving operational excellence to support our high-quality standards.

Main tasks:

Quality Mangement & Compliance

• Build, implement, and maintain a QMS that complies with ISO 13485, FDA 21 CFR Parts 210/211 (pharmaceuticals), and GMP/GLP requirements.
• Ensure compliance across medical devices, pharmaceuticals, and cosmetics in alignment with FDA, EMA, and other global regulatory agencies.
• Work closely with CMOs (Contract Manufacturing Organizations) to drive process excellence and maintain quality oversight.
• Manage product specifications, including development, scale-up, and implementation.
• Oversee CAPA processes, change control, and risk management.
• Evaluate, audit, and ensure compliance of suppliers & CMOs.

Regulatory Affairs & Markets Approvals

• Develop and execute regulatory strategies for obtaining market clearances and approvals for medical devices, pharmaceuticals, and cosmetics in key global markets.
• Lead discussions with FDA, notified bodies, and other regulatory authorities, ensuring compliance with evolving regulations.
• Maintain Regulatory Intelligence, keeping the organization up to date on industry and compliance trends.
• Manage external regulatory consultants and support collaboration within the vVardis Group.
• Leadership & Team Development
• Foster cross-functional collaboration between R&D, manufacturing, supply chain, and commercial teams.
• Promote a culture of continuous improvement, compliance, and operational excellence.

Qualifications and Skills:

• Minimum 5 years of experience in Quality Assurance & Regulatory Affairs within medical devices, pharmaceuticals, or cosmetics.
• Strong expertise in ISO 13485, FDA 21 CFR Parts 210/211, GMP, GLP, and global regulatory requirements.
• Auditing experience (internal & external) is a strong advantage.
• Fluent in English and German (written & spoken).
• Strong analytical and problem-solving skills with a results-driven mindset.
• Proficient in MS Office Suite and document management systems.
• Excellent organizational, time management, and interpersonal skills.
• Proactive, adaptable, and capable of working in a fast-paced, changing environment.
• Ability to lead projects independently while fostering strong team collaboration.
• Service-oriented mindset, ensuring compliance while driving business efficiency.

Your Personality:

You’re excited to be a member of a dynamic team and to contribute to building our business. You easily adapt to change and take an active, continuous improvement approach to leading our business. The role involves many points of contact internally and externally, so it is important that you can build collaborative relationships across teams and functions. Being part of a new, small, and nimble organization, you are expected to be a self-sufficient, self-starter individual, ready to roll up your sleeves and strive for the good of the wider business at all times. Our company standards and ethics are very high, and it is imperative that you embody them with your own behavior. You are a fast learner, a doer with a low-ego personality, and you strive for excellence in execution.

This is a permanent position with vVARDIS where you will have the opportunity to grow in your career.

vVARDIS is an equal opportunities employer and welcomes applications from all suitably qualified persons.

Join vVARDIS: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about vVARDIS and our career opportunities, join the vVARDIS Network on LinkedIn:

If you don’t hear from us, please know that we highly value your interest in vVARDIS and encourage you to stay connected for future opportunities.

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