Compliance Specialist IV

Antler; New Brunswick (NJ); On-site; USD 134,000 - 148,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Johnson & Johnson Health Care Systems Inc. is seeking a Compliance Specialist IV to develop and oversee Quality and Compliance programs for Med Tech US field inventory across the NA Region.

The role involves coordinating with Quality, Distribution, Sales, Commercial, and Supply Chain teams to resolve quality issues and drive improvements in field inventory and loaner programs. The position requires leading audits and investigations, ensuring regulatory compliance (FDA/ISO-13485), and developing

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation.

Responsibilities

• Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region.
• Support last mile delivery of surgical loaner sets to joint reconstruction and orthopedic customers across the US.
• Liaise with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality issues.
• Identify and implement improvement opportunities aligned with business objectives and Enterprise Quality Standards.
• Define, implement, and validate quality requirements and systems in line with departmental strategies.
• Lead audits, inspections, investigations, and remediation activities.
• Ensure the Quality program maintains regulatory compliance.
• Develop, implement, and review standard operating procedures.
• Establish relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers.
• Execute and improve systems in inspection readiness; quality programs; process changes; validation and maintenance systems; and nonconformance actions.

Skills

Lean management

Quality Assurance

Audit management

Validation and compliance

SOPs development

Process improvement

Quality oversight

FDA regulations

ISO-13485

Telecommute

Domestic travel

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

New Brunswick, New Jersey, United States of America

Job Description

Employer: Johnson & Johnson Health Care Systems Inc.

Job Title: Compliance Specialist IV

Job Code: A011.7404.7

Job Location: New Brunswick , NJ

Job Type: Full-Time

Rate of Pay: $134,000 - $148,000/year

Job Duties: Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC). Support "last mile" delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US. Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues. Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards. Define, implement, and validate quality requirements and systems in alignment with departmental strategies. Participate in and lead audits, inspections, investigations, and remediation activities. Ensure the Quality program maintains regulatory compliance. Provide quality support for existing and new distribution processes. Develop, implement, and review standard operating procedures. Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments. Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring.

Requirements: Employer will accept a Bachelor's degree in Engineering, Life Sciences, or related field and 6 years of experience in the job offered or in a Compliance Specialist IV-related occupation.

Position Requires Experience With

• Lean management and Quality Assurance;
• Quality program leadership;
• Audit management;
• Validation and compliance;
• Standard Operating Procedures (SOPs) development, implementation, and review;
• Process improvement activities including value-based healthcare, Agile methodology, root cause analysis, statistical process control, and process mapping and reengineering;
• Quality oversight of external sales agents/consignment models;
• Health Authority or notified body;
• FDA regulations and ISO-13485 standards.
• May telecommute.
• Up to 20% domestic travel required.

This job posting is anticipated to close on 9/17/2026.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

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
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits