Regulatory Compliance Specialist II - Ctrl Room Mgmt
Williams
Full-timeIn person
Posted
Oct 31, 2026
Closes
Jan 29, 2027
Job Description
Regulatory Compliance Specialist II - Ctrl Room Mgmt
Skills & Competencies
Skills relevant to this opportunity
Domestic and international regulatory submissions — lead end-to-end preparation, review, and filing across multiple simultaneous complex product programs.
Regulatory agency relationships — conduct pre-submission meetings and ongoing correspondence autonomously to negotiate pathways and resolve open issues.
Non-routine agency inquiries — prepare and deliver comprehensive technical responses independently, drawing on deep knowledge of applicable regulations and product science.
Regulatory pathway strategy — determine the optimal submission strategy for novel devices or products by applying inductive and deductive reasoning to ambiguous regulatory frameworks.
Corporate regulatory policy — interpret new or revised rules and translate them into updated policies, procedures, and training materials distributed across the organization.
Technical files for complex products — oversee maintenance and gap analysis of multi-market approval documentation to sustain regulatory status across jurisdictions.
