Chief Regulatory & Compliance Officer

Overview:

We are seeking a seasoned and strategic Chief Regulatory & Compliance Officer to lead all regulatory affairs, quality systems, and compliance functions as we scale commercialization of our FDA-cleared Class II medical devices. This role will be instrumental in shaping our global regulatory strategy, ensuring ongoing compliance with FDA, EU MDR, and other applicable international standards, and supporting cross-functional initiatives to accelerate time-to-market.

Key Responsibilities:

• Develop and execute global regulatory strategy to support product launches, labeling, and market expansions

• Serve as the primary liaison with regulatory bodies (e.g., FDA, EMA) and notified bodies to manage submissions, audits, and post-market surveillance

• Lead preparation and submission of 510(k)s, technical files, CE Mark dossiers, and other regulatory documents

• Establish and maintain quality management systems (QMS) compliant with FDA 21 CFR Part 820, ISO 13485, and ISO 14971

• Oversee risk management programs, regulatory inspections, adverse event reporting, and CAPA investigations

• Collaborate with R&D, Clinical, Legal, and Operations teams to embed compliance into product development and lifecycle management

• Monitor changes in global regulatory requirements and implement necessary policy updates and training

• Build and lead the regulatory, quality, and compliance teams as needed to support company growth

Qualifications:

• 15+ years of experience in regulatory affairs and compliance, including 5+ years in a senior leadership role

• Demonstrated success securing and maintaining FDA 510(k) clearances and EU regulatory approvals for medical devices

• Deep knowledge of QMS, clinical evaluations, labeling, and post-market requirements

• Experience interacting directly with FDA and other regulatory authorities

• Strong leadership, communication, and cross-functional collaboration skills

• Advanced degree in Regulatory Science, Life Sciences, Biomedical Engineering, or related field preferred

Compensation:

• Competitive base salary ($275K–$375K depending on experience)

• Bonus eligibility and equity participation

• Comprehensive benefits package