Regulatory and Compliance Manager - Health-Tech

A pioneering healthcare technology company is transforming the industry with advanced AI solutions that enhance the efficiency and quality of care provided by nurses and frontline staff. By addressing global nursing shortages, the company's technology enables hospitals and care homes to deliver effective, stress-free patient care.

The company is currently looking for a highly motivated and detail-oriented Regulatory and Compliance Manager to join its team in Copenhagen. This essential role involves ensuring that AI products and services adhere to all relevant regulations, including GDPR, MDR, the AI Act, and more. The specialist will navigate the complex legal landscape of AI in healthcare to ensure that solutions meet the highest standards of regulatory compliance.

Key Responsibilities:

• Be Company responsible for all regulatory and compliance matters including to provide training and guidance to staff on compliance-related matters and liaise with external legal advisors and regulatory bodies as needed.
• Monitor and analyze regulatory developments in AI, healthcare, and data protection.
• Ensure compliance with GDPR, MDR, AI Act, CE-Marking, and other relevant regulations, as well as future requirements such as FDA compliance.
• Collaborate with product and development teams to integrate compliance requirements into solutions.
• Manage and report on compliance activities for annual management reviews.
• Coordinate and facilitate compliance audits, including annual GDPR audits (SOC 2 or ISAE 3000) and MDR audits.
• Conduct risk assessments and develop comprehensive documentation of compliance activities currently utilizing tools like Vanta and OpenRegulatory.
• Assist potential and current customers in understanding the relevant laws and regulations concerning the system.

Requirements:

• Bachelor’s or Master’s degree in relevant field.
• Strong understanding of the healthcare industry and AI technologies.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to work independently in complex regulatory environments.