Principal Regulatory Affairs Specialist/Engineer (SaMD)

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Requirements:

• Bachelor’s degree in life sciences, engineering or other relevant fields, advanced degree preferred.
• 15+ years of experience in regulatory affairs management, preferably with AI and SaMD.
• Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices.
• Proven ability to lead regulatory and quality initiatives, including successful FDA submissions and audits.
• Familiarity with QMS software and tools, as well as regulatory submission platforms.
• Strong communication and interpersonal skills, with the ability to engage cross-functional teams and external stakeholders.
• 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.
• RAC (Regulatory Affairs Certification) or similar credentials are a plus

Responsibilities:

• 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.
• Develop and implement regulatory strategy to ensure advancement of product pipeline and business continuity.
• Develop regulatory plans for devices currently commercialized, devices undergoing FDA review per TAP and Breakthrough Device Designation programs.
• Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
• Establish and maintain company policies and procedures to support regulatory and quality initiatives.
• Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
• 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.
• Provide training and guidance to internal teams on regulatory and quality requirements.
• Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
• 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.