Senior Specialist, Commercial Quality & Regulatory Affairs

Lead pre-market and post-market regulatory activities for IVD devices, including the preparation of technical documentation and submissions to health authorities. Oversee quality management processes, compliance operations, and act as the Quality Management Representative when required. Requires a Bachelor's degree with 6+ years of experience, or a medical device certificate with 3+ years of experience. Must possess strong knowledge of regulatory guidelines for diagnostic products and the ability to manage multiple priorities in a fast-paced environment.