Job Summary:
The Regulatory Affairs Specialist/Senior Specialist for Drug-Device Combination Products will serve as an essential resource within the organization, providing technical expertise and regulatory guidance for the development, manufacturing, and commercialization of drug-device combination products. This role ensures compliance with regulatory standards, drives adherence to best practices, and supports the full lifecycle management of combination products. Strong cross-functional collaboration and communication skills are required to ensure alignment across teams, alongside a deep understanding of regulatory pathways for these products.
Key Responsibilities:
Maintain comprehensive knowledge of regulatory standards and guidelines governing drug-device combination products, specifically FDA regulations (e.g., 21 CFR 210/211, 21 CFR 820 QSR & 21 CFR Part 4) and ISO 13485 standards.
Support device/drug-device combination product development from concept through lifecycle management, providing guidance to ensure regulatory compliance.
Coordinate with the device manufacturer, reviewing the design history file, FMEA, documents checklist in absence of 510(K).
Knowledge of Type-V DMF for CDER-Led combination products using device constituent parts. Guide and consult the team regarding administrative and technical requirements.
Offer technical expertise in development, testing, and manufacturing processes for drug-device combination products, including compatibility testing, stability studies, process validation, and cleaning validation.
Stay informed on emerging trends, regulations, and technologies related to drug-device combination products to identify opportunities for process improvements and streamline regulatory processes.
Prepare and submit New Product Applications for drug-device combination products to regulatory agencies, primarily the US FDA, ensuring timely and accurate submissions.
Assess regulatory reporting requirements using FDA regulations, guidance documents, and inhouse policies for change control documentation on drug-device combination products.
Develop and maintain regulatory trackers and databases to monitor submission timelines, track regulatory changes, and communicate updates to relevant stakeholders.
Partner with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to compile required information and ensure compliance for all new products, changes to existing products, and post-market activities related to drug-device combination products.
Education: Bachelors degree in Life Sciences, Regulatory Affairs, Chemistry, Engineering or a related field. Advanced degrees or certifications in Regulatory Affairs (e.g., RAC) are a plus.
Experience:
Minimum of 3-5 years of experience in regulatory field within the pharmaceutical, biotechnology, or medical device industry with specific expertise in drug-device combination products (DDCP).
Current, in-depth knowledge of FDA guidelines and regulatory requirements for drug-device combination products (CFR 21)