Regulatory Affairs Specialist

Role: Industry Consulting Senior Consultant (Regulatory Affairs Specialist)

Location : Remote (California)

Job Summary:

We are seeking an experienced Regulatory Affairs Specialist with expertise in medical device registration across Asian markets. The role involves leading cross-border regulatory submissions, ensuring compliance with country-specific requirements, and managing the end-to-end registration process. This position demands strong product and regulatory knowledge, excellent project management skills, and adaptability to diverse cultural and market conditions.

Key Responsibilities:

• Regulatory Strategy & Compliance
• Develop and execute regulatory strategies for medical device registration across multiple Asian countries (e.g., China, Japan, South Korea, ASEAN nations).
• Ensure compliance with regional regulatory frameworks, including country-specific classification systems, technical documentation standards, and submission processes.
• Documentation & Gap Analysis
• Prepare, review, and maintain technical dossiers in accordance with each market s requirements.
• Conduct gap analyses of existing documentation and implement corrective actions to meet regulatory standards.
• Cross-Border Coordination
• Liaise with regulatory authorities, local agents, and in-country partners to streamline submissions.
• Coordinate regulatory activities across multiple time zones and cultural contexts.
• Market-Specific Adaptation
• Adapt regulatory strategies based on local cultural, business, and market conditions.
• Monitor and interpret regulatory updates in target markets to ensure ongoing compliance.
• Project Management
• Oversee end-to-end registration projects, ensuring timely submissions and approvals.
• Manage cross-functional collaboration with R&D, Quality Assurance, and Commercial teams.

Education & Experience:

• Bachelor s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related field (master s preferred).
• 5+ years of experience in regulatory affairs, specifically in medical device registration, with exposure to multiple Asian markets.

Technical Skills:

• Strong understanding of medical device classification systems, regulatory submission formats, and technical documentation requirements.
• Familiarity with country-specific authorities (e.g., NMPA, PMDA, HSA, CDSCO, TFDA, MFDS).
• Experience with gap analysis and remediation planning for technical files.
• Proficiency in regulatory software systems and electronic submission portals.

Core Competencies:

• In-depth product and regulatory knowledge.
• Ability to develop and implement cross-border regulatory strategies.
• Strong analytical, documentation, and problem-solving skills.
• Cultural and market-specific adaptability with sensitivity to diverse business practices.
• Project management excellence, including multi-country coordination.

Strong communication and stakeholder management skills in an international context