Regulatory Specialist : FDA & Global Compliance - Full Time Hybrid

Regulatory Specialist: FDA & Global Compliance

We are looking for a Regulatory Specialist: FDA & Global Compliance to join our team. This role is pivotal in ensuring regulatory compliance of our Software as a Medical Device (SaMD) products across the US and international markets. The position will focus on FDA regulatory activities, including pre-submissions, 510(k), and DeNovo pathways, while also supporting MDR compliance, QMS processes, and global regulatory strategy.

As part of a growing team, this role offers the opportunity to shape regulatory processes, support clinical and product development, and contribute to the company's expansion into new markets and certifications.

Key Responsibilities

FDA Regulatory Compliance

• Prepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough Designation
• Ensure completeness and compliance of all regulatory documentation
• Coordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)

US Compliance & Reimbursement

• Support development of US reimbursement strategy (CPT codes, payer engagement)
• Ensure compliance with FDA, SOC2, and future MDSAP requirements
• Support SOC2 certification processes and data privacy/security compliance

MDR & International Regulatory

• Support MDR compliance and technical documentation
• Ensure alignment with ISO 13485 and ISO 14971 requirements
• Contribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)

Quality Management System (QMS)

• Maintain and improve QMS processes related to regulatory compliance
• Review promotional and training materials for regulatory compliance
• Support design control, risk management, and documentation updates

Audits & Compliance

• Support internal, external, and notified body audits
• Perform risk assessments and usability evaluations
• Support supplier/distributor evaluation and compliance processes

Cross-functional Collaboration

• Work with clinical teams on retrospective and prospective studies
• Collaborate with R&D, product, and legal teams on regulatory requirements
• Support regulatory input in product development and change management

Continuous Improvement

• Improve regulatory and quality processes
• Support integration of compliance into development lifecycle
• Monitor regulatory landscape (FDA, MDR, global)