Remote Senior Regulatory Affairs Specialist

Summary

Join Artera, an AI startup developing personalized therapy for cancer patients, as a Regulatory Affairs Specialist to ensure compliance and streamline product approval.

Requirements

• 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

Responsibilities

• 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

Benefits

• 401k matching
• Unlimited paid time off (PTO)