Sr Manager Regulatory and Clinical Affairs
Core
Develop and execute regulatory strategy and clinical evidence generation plans to support product claim expansions and regulatory submissions for in vitro diagnostics.
Role type
Senior Manager, Regulatory and Clinical Affairs
Builds
Regulatory submissions and clinical evidence packages for diagnostic assays
Domain
In vitro diagnostics / Laboratory diagnostics
Deliverable
client delivery
Required skills
Global regulatory pathway strategy, clinical study planning and execution, CRO and clinical site management, biostatistics and clinical performance evaluation, risk management, labeling and claims development
Preferred skills
Advanced degree in life sciences or related field, 10+ years experience in IVD regulatory affairs
Technologies
FDA submission frameworks (510(k), De Novo, PMA), EU IVDR compliance tools
Responsibilities
Develop and execute regulatory strategies for product claim expansions and new market access; Coordinate clinical study planning, execution, and data review to support regulatory submissions; Manage external partners (CROs, labs, investigators) to ensure compliance and on-time delivery; Lead cross-functional teams and influence stakeholders to align on regulatory feasibility and business impact.
Seniority
Senior, hands-on IC with people management
