The Regulatory Affairs Specialist Consultant leads regulatory strategy and submissions for a novel robotic medical device across US and global markets. This role prepares regulatory documents, supports clinical and quality teams, ensures compliance with ISO 13485, 21CFR820, EU MDR, and global regulations, and manages interactions with regulatory agencies. The position requires deep experience with high-risk devices, Design Controls, risk analysis, Technical Files, Design Dossiers, Clinical Evaluation Plans/Reports, and Post Market Surveillance activities.

Responsibilities

• Formulate and execute regulatory submission activities for US, EU, and international markets.
• Prepare and author Design Dossiers, Technical Files, Device License Applications, IDEs, De Novo and PMA submissions.
• Support regulatory interactions with FDA and Notified Bodies.
• Lead Clinical Evaluation and Post Market Surveillance reporting.
• Define regulatory requirements for new product development and ensure adherence to Design Control SOPs.
• Support document change control and review validation protocols for submissions.
• Maintain knowledge of regulatory standards, ensure global compliance, support clinical operations, and manage complex regulatory challenges.

Qualifications

• Bachelor's in scientific discipline required; Master's preferred.
• 15+ years in clinical and regulatory affairs with proven approvals.
• Expertise in ISO 13485, 21CFR820, EU MDR 2017/745.
• Experience with high-risk devices, De Novo/PMA submissions, Technical Files, Design Dossiers, global premarket requirements, project management tools, IDE submissions, robotic/electromechanical/AI/SaMD systems, FDA QSIT and BIMO inspections, and Notified Body audits.
• RAC-devices preferred; able to work in fast-paced environment; travel up to 5%.