Principal Regulatory Affairs Specialist/Engineer (SaMD)

We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Senior Regulatory Specialist must be experienced and thoughtful about the processes necessary for achieving domestic and regulatory approval. 

You'll be joining a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team and communicating daily with the product manager. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare diagnosis systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.

Responsibilities

Key Responsibilities:

• Product Certification: Lead efforts for regulatory submissions and approvals, including FDA traditional and special 510(k) submissions, de novo requests, CE marking, and other certifications required for market entry.
• Submission Management: Develop and implement regulatory strategy to ensure advancement of product pipeline and business continuity.
• Regulatory Planning: Develop regulatory plans for devices currently commercialized, devices undergoing FDA review per TAP and Breakthrough Device Designation programs.
• Risk Management: Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
• Policy Development: Establish and maintain company policies and procedures to support regulatory and quality initiatives.
• Cross-Functional Collaboration: Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
• Audits and Inspections: Support internal and external audits, including FDA and ISO inspections, and ensure readiness for all regulatory reviews including technical files, dossiers, Medical Device DHFs, etc.
• Training and Support: Provide training and guidance to internal teams on regulatory and quality requirements.
• Continuous Improvement: Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
• Regulatory Intelligence: Stay current with changes in regulations, standards, and industry trends, ensuring the company remains ahead of compliance requirements.
• Escalates business critical information in relation to regulatory impact. Evaluate risk and regulatory solutions to product and clinical safety issues during clinical phases.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Draft Pre-Submission and regulatory application documents.Represent the company’s objectives and strategy while communicating with FDA and other regulatory bodies.
• Perform regulatory assessment of product changes, develop and implement processes to ensure regulatory compliance and risk based change assessments.
• Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
• Prepare, or contribute to the preparation of post market surveillance plans and evaluate post-market data.

Qualifications and Experience:

• Bachelor’s degree in life sciences, engineering or other relevant fields, advanced degree preferred.
• Experience: 15+ years of experience in regulatory affairs management, preferably with AI and SaMD.
• Expertise: Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices.
• Leadership: Proven ability to lead regulatory and quality initiatives, including successful FDA submissions and audits.
• Technical Skills: Familiarity with QMS software and tools, as well as regulatory submission platforms.
• Communication: Strong communication and interpersonal skills, with the ability to engage cross-functional teams and external stakeholders.
• Problem-Solving: Skilled in identifying and addressing regulatory and quality challenges proactively.

• Experience with new product development standards and documentation for software products.
• Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
• Ability to communicate and interact with regulatory agencies and consultants.
• Excellent written and verbal skills.
• Certifications: RAC (Regulatory Affairs Certification) or similar credentials are a plus

Salary: $179,000 - $272,000

 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.