Associate Director, Laboratory Operations, Logistics and Safety Compliance (Onsite)
Core
Lead Laboratory Operations, Logistics, and Safety Compliance for device and combination product development labs to enable safe, compliant, and efficient environments for innovative medicines and medical devices.
Role type
Associate Director, Laboratory Operations & Safety Compliance
Builds
Device and combination product development laboratories (engineering, testing, human factors)
Domain
Medical Devices / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory operations leadership, EHS compliance, FDA 21 CFR Part 820, ISO 13485, equipment lifecycle management, risk assessment, incident investigation, team leadership, regulatory inspection support
Preferred skills
Combination product development, human factors laboratory experience, EHS professional certification, operational excellence
Technologies
None explicitly listed
Responsibilities
Provide strategic and operational leadership for medical device development laboratories; oversee lab operations ensuring efficiency and compliance; manage equipment lifecycle processes; ensure compliance with OSHA and global safety requirements; lead safety programs for device-specific hazards; partner with R&D for design verification and validation; support regulatory inspections and audits; lead and develop a team responsible for lab operations and safety
Seniority
Senior, hands-on IC with leadership responsibilities
