Director, Regulatory Affairs
Core
Build and lead global regulatory strategy for in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation products to support market authorization and commercial expansion.
Role type
Director, Regulatory Affairs (Strategic Leader & Hands-on Builder)
Builds
Global regulatory infrastructure, strategies, and capabilities for IVD and NGS portfolios
Domain
Life Sciences / Medical Devices / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (regulatory pathways, market authorization, lifecycle management)
Required skills
Global regulatory strategy, IVD and medical device expertise, FDA and EU IVDR experience, stakeholder management, team building/scaling, risk assessment, cross-functional leadership
Preferred skills
Advanced degree, RAC certification, experience with complex diagnostic instruments
Technologies
ISO 13485, ISO 14971, FDA, EU IVDR
Responsibilities
Lead global regulatory strategy for IVD, NGS, and life science instrumentation; Advise executive leadership on regulatory pathways and risks; Establish regulatory governance and decision-making mechanisms; Lead interactions with regulatory authorities and external stakeholders; Build and scale the Regulatory Affairs function; Manage post-market reporting and vigilance obligations.
Seniority
Director, strategic leadership with hands-on execution