Job Details

Responsibilities :

• Develop regulatory strategies, review design input/output documentation, identify applicable standards, perform regulatory assessments, prepare submissions, maintain filings and licenses, and interact with regulatory agencies.
• Serve as the global regulatory liaison and primary contact for product and project teams related to Paragon software applications and surgical system hardware.
• Maintain expertise in regulations, legislation, and guidelines related to Artificial Intelligence, Software as a Medical Device, and Machine Learning (SaMD / ML).
• Provide regulatory guidance, develop strategies, and review product design control documentation.
• Determine regulatory pathways and formulate strategies for various markets.
• Assess regulatory impact on design, materials, labeling, packaging, manufacturing, and facilities.
• Handle FDA (k), De Novo applications, Letters to File, and pre-submissions with minimal supervision.
• Coordinate with technical experts for additional data requests and prepare responses to regulatory agencies.
• Provide risk-based guidance and regulatory input, ensuring cross-functional alignment.
• Collaborate internationally to support global submissions, approvals, and rollouts.
• Build relationships and interface with cross-functional teams (Engineering, Manufacturing, Marketing, etc.).
• Conduct regular training on software development, SaMD, and cybersecurity.
• Assess changes in laws and regulations, identify impacts, and develop strategies accordingly.
• Support regulatory inquiries and audits.
• Review global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
• Mentor junior team members.

Requirements :

• Bachelor's degree in Engineering, Biology, Regulatory Science, or related field, with relevant experience or equivalent education and experience.
• Proven experience with SaMD and mobile health app regulations.
• In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps.
• Experience with (k) / De Novo submissions for connected orthopedic or wearable devices.
• Familiarity with IEC, ISO, and FDA Part compliance for software validation.
• Experience with EU MDR requirements for software and app-based devices (Annex I & XIII).
• Effective collaboration with software, clinical, and human factors teams.
• Post-market compliance expertise, including UDI, vigilance, and software change reporting.
• Strong understanding of cybersecurity requirements (FDA, IMDRF).
• Knowledge of US and international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
• Experience with regulatory submissions for AI, SaMD, and ML products.
• Attention to detail, organizational skills, ability to prioritize and complete projects.
• Proficiency in Excel, Word, PowerPoint, Outlook, and database management systems.
• Leadership and negotiation skills, ability to manage cross-departmental expectations.
• Excellent communication skills.