Regulatory, Safety & Compliance Director
Core
Leads division-level Regulatory Affairs, Product Safety, and Compliance programs for Electron Microscopy and EFA instruments to ensure global regulatory adherence and safe product lifecycle management.
Role type
Senior IC Regulatory, Safety & Compliance Director
Builds
Compliant Electron Microscopy and EFA instruments for global markets
Domain
Life Sciences / Analytical Instrumentation / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory framework expertise (CE, NRTL, FCC, WEEE, RoHS, REACH, SCIP), Product Safety & Compliance program leadership, Stage-gate review input, KPI definition for compliance processes, CAPA and RCCM methodologies, Audit and third-party inspection management, Safety Data Sheets (SDS) development, Regulatory intelligence and emerging regulation monitoring, New product development compliance from concept to commercialization, Team recruitment, hiring, coaching, and mentoring, Practical Process Improvement (PPI) management, Industry standards body participation
Preferred skills
Electron microscopy or analytical instrumentation domain experience, Product lifecycle process (PMP/PLC) and stage-gate governance expertise, Quality systems and field incident management experience, Continuous improvement methodologies (PPI, Lean, Six Sigma), Regulatory or industry standardization organization participation
Technologies
CE, NRTL, FCC, WEEE, RoHS, REACH, SCIP, PMP, PLC, CAPA, RCCM, PPI, Lean, Six Sigma
Responsibilities
Lead MSD-wide Product Safety & Compliance program, Ensure adherence to global regulatory requirements for instruments and consumables, Identify and maintain applicable regulations for each market, Provide input for stage-gate reviews within the Product Management Process, Define and implement KPIs for compliance processes, Serve as subject matter expert in global regulatory frameworks, Lead the Product Quality Advisory Committee for field incidents, Support internal and external audits and manage coordination with test laboratories, Ensure Safety Data Sheets are developed and maintained, Drive Regulatory Intelligence by monitoring emerging regulations, Establish systems for new product development compliance, Recruit and mentor a high-performing team, Represent Regulatory Safety & Compliance in the Product Lifecycle Council, Act as PPI Process Manager, Participate in industry organizations and standards bodies
Seniority
Senior, hands-on IC with team leadership