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
Average salary estimate
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