Regulatory Specialist : FDA & Global Compliance - Full Time Hybrid

RetinAI Medical

4d • Hybrid

About The Position

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.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field
• 7+ years of experience in regulatory affairs (FDA focus)
• Experience with FDA submissions (510(k), DeNovo, Pre-Sub)
• Experience with SaMD (Software as a Medical Device)
• Experience with ISO 13485 and ISO 14971
• Experience with MDR and EU regulatory framework
• Knowledge of clinical studies (retrospective & prospective)
• Strong analytical and problem-solving abilities
• High attention to detail
• Ability to manage multiple projects simultaneously
• Strong communication and stakeholder management skills
• Ability to work cross-functionally in an international environment
• Excellent verbal and written English communication skills

Nice To Haves

• Understanding of US reimbursement landscape is a plus
• Experience with SOC2 / MDSAP is a plus

Responsibilities

• 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)
• 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
• 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)
• 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
• Support internal, external, and notified body audits
• Perform risk assessments and usability evaluations
• Support supplier/distributor evaluation and compliance processes
• 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
• Improve regulatory and quality processes
• Support integration of compliance into development lifecycle
• Monitor regulatory landscape (FDA, MDR, global)

Benefits

• A competitive salary in a supportive work environment that fosters work-life balance.
• Opportunities for professional growth and development in an international setting.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior