Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biological Research
Job Category:Scientific/Technology
All Job Posting Locations:Irvine, California, United States of America
Job Description:Johnson & Johnson MedTech, Electrophysiology, is recruiting a
Preclinical Compliance Associate This position is located in
Irvine, CA and will be following a hybrid model.
Purpose: The Preclinical Compliance and Planning Associate will drive contract-research lab strategies, ensure compliance with all internal and external animal welfare requirements, collaborate on strategic partnerships, manage project timelines, and oversee process improvements to improve the functioning of the Preclinical Research Department.
You will be responsible for:- Act as primary coordinator for CRO strategy and execution: evaluate when to outsource vs. perform work internally, select vendors, and manage study handoffs and timelines.
- Develop, review, and enforce Standard Operating Procedures (SOPs)
- Design, implement, and manage chemical, biological, and radiological safety programs, including CAPA (corrective and preventive action) processes.
- Manage preventive maintenance, calibration, and service schedules for critical equipment (e.g., biosafety cabinets, anesthesia systems, radiology devices).
- Identify, qualify, and onboard external laboratories and service providers using a structured supplier qualification process and required documentation.
- Manage outsourcing relationships and vendor communications to ensure deliverables meet scientific, quality, and compliance expectations.
- Serve as the lab scheduling and resource-allocation lead to optimize facility usage, reduce bottlenecks, and support project timelines.
- Coordinate procurement for lab usage and research materials: generate purchase requests, manage budgets, and track expenses with finance partners.
- Monitor and manage finance/budget aspects for preclinical operations, including forecasting, tracking spend vs. plan, and identifying cost-saving opportunities.
- Create and maintain job descriptions and role expectations for preclinical staff; support hiring and onboarding processes.
- Track and report key performance indicators (KPIs) and operational metrics (e.g., study throughput, animal census, equipment uptime, training compliance) to leadership.
- Maintain an annual calendar of important regulatory, accreditation, and operational milestones to ensure proactive planning and timely submissions.
- Manage documentation control, record retention, and data integrity practices to support audits and reproducible science.
- Drive continuous improvement initiatives across operations, quality, and compliance, and lead cross-functional corrective/preventive actions.
Qualifications / Requirements:- A minimum of a Bachelor's Degree
- A minimum of 2 years of relevant experience is required
- Proven track record of contributing to medical programs on time, within budget and in compliance to SOPs and regulations is required.
- Up to 25% domestic and international travel may be required.
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Critical Thinking, Data Analysis, Data Savvy, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Product Development Lifecycle, Report Writing, Stakeholder Engagement, Technologically Savvy
The anticipated base pay range for this position is :$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
