Regulatory and Compliance Specialist

• Regulatory, Compliance & Law
• Full-time
• Copenhagen, DK

At Teton, we're revolutionizing the healthcare industry with cutting-edge AI solutions designed to support nurses and frontline care staff. Our technology addresses global nursing shortages by enabling hospitals and care homes to provide efficient, stress-free patient care.

We are seeking a highly motivated and detail-oriented Regulatory and Compliance Specialist to join our team in Copenhagen. This role is critical in ensuring that our AI products and services comply with all relevant regulations, including GDPR, MDR, the AI Act and more. You will be responsible for navigating the complex legal landscape of AI in healthcare, ensuring our solutions meet the highest standards of regulatory compliance.

This position is particularly suited for individuals who are keen to grow in their career and expand their knowledge base. While we value experience, we are equally excited about candidates who are passionate about the field, driven to learn, and eager to contribute in a hands-on manner. We believe in nurturing talent and providing opportunities for professional development.

Key Responsibilities:

• Monitor and analyze regulatory developments in AI, healthcare, and data protection.
• Ensure compliance with GDPR, MDR, AI Act, CE-Marking and other relevant regulations, along with future needs such as FDA.
• Collaborate with product and development teams to integrate compliance requirements into our solutions.
• Manage and report compliance activities to the management for annual reviews.
• Coordinate and facilitate compliance audits, i.e. a yearly GDPR audit (SOC 2 or ISAE 3000) and MDR audits.
• Manage ongoing regulatory activities including medical device application/certification processes.
• Conduct risk assessments.
• Develop and maintain comprehensive documentation of compliance activities. We use Vanta and OpenRegulatory right now.
• Provide training and guidance to staff on compliance-related matters.
• Liaise with external legal advisors and regulatory bodies as needed.
• Help potential and current customers to understand relevant law and regulation concerning our system.

Requirements:

• Bachelor’s or Master’s degree in Law, Commercial Law, Regulatory Affairs, or a related field.
• Proven experience in regulatory compliance is ideal, but not mandatory. We welcome candidates who are new to GDPR, MDR, and AI-related regulations but are enthusiastic about learning and growing in this field.
• Strong understanding of the healthcare industry and AI technologies.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to work independently and navigate complex regulatory environments.
• Strong communication skills, both written and verbal.

What Teton Offers:

• A dynamic, innovative work environment where you can drive change and make a significant impact.
• A talented team passionate about learning, innovation, and making a difference.
• A well-equipped office designed to foster a great working environment.

We offer a competitive salary, and all full-time employees are included in our warrant program (stock options). Following our successful second round of funding, we're providing sizable warrant packages. You'll also enjoy a well-equipped office designed to create a great working environment.

Join Our Team:
If you are passionate about AI, healthcare, and ensuring ethical and legal compliance in a fast-paced, innovative environment, we would love to hear from you. Let's make a difference, together! ??