Join Us to Help Transform Emergency Care Worldwide

We are seeking a Head of Quality and Regulatory Affairs to lead the development and implementation of our quality and compliance strategy. This role is critical to ensuring that Noramber’s products meet the highest standards for safety, efficacy, and regulatory compliance, with a particular focus on U.S. FDA and EMA requirements and. You will be responsible for building and maintaining an electronic Quality Management System (eQMS) and managing regulatory documentation workflows across the company.

Key Responsibilities

• Develop and maintain a company-wide eQMS aligned with ISO 13485 and ISO 14971.

• Lead regulatory strategy and submissions for FDA clearance (e.g., 510(k), De Novo).

• Ensure compliance with HIPAA, GDPR, and Norwegian health data regulations.

• Oversee electronic documentation systems for regulatory submissions and audits.

• Manage risk assessment processes for AI-based medical software and telehealth tools.

• Coordinate with clinical, technical, and legal teams to ensure cross-functional compliance.

• Prepare and manage regulatory submissions, including interactions with FDA and EMA.

• Support post-market surveillance, labeling, and clinical claims documentation.

Essential Qualifications

• Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Health Technology, or related field.

• Minimum 5 years of experience in medical device or digital health regulatory affairs.

• Proven experience with FDA regulatory processes (510(k), De Novo, QSR).

• Familiarity with EMA and European MDR frameworks.

• Hands-on experience with electronic QMS platforms and regulatory documentation systems.

• Strong understanding of ISO 13485, ISO 14971, and risk management in health tech.

• Experience with HIPAA, GDPR, and health data governance.

• Excellent communication and documentation skills.

Preferred Qualifications

• Experience with AI-based medical software or SaMD (Software as a Medical Device).

• Prior involvement in telehealth, prehospital care, or emergency medicine projects.

• Familiarity with Norwegian healthcare systems and regulatory bodies.

• Experience working in startup or early-phase innovation environments.

What We Offer

• A unique opportunity to shape the future of emergency healthcare.

• Collaboration with leading clinical and technical experts.

• Flexible working arrangements.

• Competitive compensation based on experience.