Senior Regulatory Affairs Specialist

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.

• Develop and execute regulatory strategies to obtain and maintain regulatory approvals for Artera’s products
• Apply strategic knowledge to product development across all stages of the product’s lifecycle, including validation strategy and post-market surveillance
• Manage regulatory timelines, priorities and resources to ensure timely product launches and updates
• Lead communications and serve as main contact with regulatory bodies, regulatory consultants, including maintenance of medical device manufacturer registrations
• Develop, review, and submit high-quality and timely regulatory agency submission materials, including clinical study reports, protocols
• Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies
• Ensure compliance with federal and state regulations across areas of product development
• Proactively identify and address regulatory compliance issues
• Support regulatory compliance audits and inspections
• Collaborate closely with cross-functional teams, including product, AI, clinical development, engineering, and legal, to ensure alignment on regulatory requirements and product development processes

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the medical device industry, with a focus on software as a medical device. Experience with AI strongly preferred.
• Proven track record of successful regulatory approvals for medical software products, including experience with de novo or 510k submissions. 
• Experience interacting with the FDA, including eSTAR submissions.
• Strong knowledge of global medical device regulations, standards, and guidelines, such as 21 CFR 820, IEC 62304, and ISO 13485.
• Familiarity with regulatory requirements for countries that utilize MDSAP.
• Understands and complies with ethical, legal, and regulatory requirements applicable to the medical device industry. 
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts to non-technical stakeholders.
• Effective leadership, management, and teamwork skills, proactive cross-functional collaborator. 
• Ability to work independently with minimal oversight and direction
• Ability to effectively manage and prioritize multiple tasks and projects
• Flexibility and adaptability to work in a dynamic and rapidly changing start-up environment
• Expected Travel: <5% domestic

Equal Employee Opportunity: At Artera, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients and physicians. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.