Associate Director, Laboratory Operations, Logistics and Safety Compliance (Onsite)

Job Description

Our Company is seeking an experienced Associate Director to lead Laboratory Operations, Logistics, and Safety Compliance supporting our device and combination product development laboratories. This role is critical in enabling safe, compliant, and efficient laboratory environments that accelerate the development of innovative medicines and medical devices for patients worldwide.

The successful candidate will bring strong prior experience in device-focused laboratory environments performing development and fit-for-purpose activities for clinical supply, including engineering labs, testing labs, and human factors/usability spaces, along with deep expertise in EHS and inspection readiness.

Primary Responsibilities

Laboratory Operations Leadership

• Provide strategic and operational leadership for laboratories supporting medical device and combination product development.

• Oversee lab operations, ensuring high standards for efficiency, reliability, and compliance.

• Manage equipment lifecycle processes, including qualification, calibration, maintenance, and decommissioning.

Safety & Environmental Health (EHS) Compliance

• Ensure compliance with OSHA regulations, corporate EHS standards, and global safety requirements.

• Lead safety programs addressing device-specific hazards (e.g., mechanical systems, electrical testing, prototyping equipment, usability testing).

• Drive proactive risk assessments, incident investigations, and CAPA implementation.

Device & Combination Product Support

• Partner with R&D and engineering teams to support design verification and validation (DV/V), human factors studies, and device testing activities.

• Ensure laboratory environments meet requirements for regulated device development and testing.

• Support regulatory inspections and audits (e.g., FDA, notified bodies) for device and combination product programs.

Facilities & Infrastructure Oversight

• Collaborate with Facilities and Engineering to maintain compliant laboratory infrastructure, including specialized device labs and test environments.

• Ensure appropriate layout, safety controls, and environmental conditions are in place to support device development workflows.

Cross-Functional Collaboration

• Serve as a key interface with Quality, Regulatory Affairs, Engineering, and EHS organizations.

• Contribute to inspection readiness efforts and represent laboratory operations during audits and governance reviews.

People Leadership

• Lead, coach, and develop a team responsible for lab operations and safety.

• Foster a strong culture of safety, accountability, and continuous improvement across lab users.

Required Education, Experience & Skills

• Bachelor’s degree in Engineering, Life Sciences, or related discipline (advanced degree preferred).

• Minimum 8+ years of relevant industry experience, including substantial experience in:

  • Medical device or drug-device combination product environments

  • Laboratory operations, technical operations, or facilities leadership

  • EHS and regulatory compliance within laboratory settings

• Demonstrated hands-on experience supporting device testing, prototyping, or engineering labs.

• Strong knowledge of:

  • FDA Quality System Regulation (21 CFR Part 820)

  • ISO 13485 and applicable device standards

  • OSHA/EHS requirements for laboratory and engineering environments

Preferred Experience & Skills

• Experience supporting combination product (drug-device) development programs.

• Familiarity with human factors/usability laboratory environments.

• Professional certification in EHS, safety engineering, or quality systems.

• Demonstrated ability to drive operational excellence and continuous improvement initiatives.

Leadership Competencies

• Strategic thinking and decision-making

• Strong collaboration and stakeholder management

• Commitment to safety, quality, and compliance

• Ability to influence across a matrixed organization

• Results-driven with a focus on patient impact

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Required Skills:

Biological Sciences, Design Thinking, Design Verification, Electronics Prototyping, Environmental Health And Safety, Labora