Job Title: Senior Regulatory Affairs Specialist
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
About Us: Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. Artera is on a mission to personalize medical decisions for patients and physicians on a global scale.
As we continue to expand our product portfolio, we are seeking a dynamic and experienced Regulatory Affairs Specialist to ensure our compliance with regulatory standards and streamline the approval process for our products. The Regulatory Affairs Specialist will be responsible for planning, directing, and coordinating regulatory activities to support Artera’s product development and product maintenance. The Regulatory Affairs Specialist will play a crucial role in guiding our products through the complex regulatory landscape and will be instrumental in securing regulatory clearances and maintaining compliance with relevant authorities, with a focus on US-based submissions. This role requires a strategic thinker with a deep understanding of regulatory requirements, excellent leadership skills, and the ability to collaborate cross-functionally to drive successful regulatory strategies. This position will make a significant impact on the culture, communication, and dynamics of a growing commercial organization. Essential ResponsibilitiesLifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
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