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Noramber AS
Gaustadalleen 21, 0349 Oslo
Om jobben
Stillingstittel
Head of Quality and Regulatory Affairs
Type ansettelse
Fast, heltid 100%
Arbeidsspråk
Engelsk
Antall stillinger
1
Arbeidssted
Hybridkontor
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...