Compliance Specialist IV

Posted 2 Days Ago
Be an Early Applicant
New Brunswick, NJ, USA
In-Office
134K-148K Annually
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Develops and oversees quality and compliance programs for medical device field inventory, loaner sites, sales offices, and distribution centers. Leads audits, inspections, investigations, remediation, validation, calibration, preventive maintenance, SOP development, process improvements, and regulatory compliance activities. Partners with Quality, Distribution, Sales, Commercial, and Supply Chain teams to resolve issues and improve delivery processes. Supports FDA and ISO 13485 compliance across commercial and distribution operations.
Summary Generated by Built In

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

1. Lean management and Quality Assurance;

2. Quality program leadership;

3. Audit management;

4. Validation and compliance;

5. Standard Operating Procedures (SOPs) development, implementation, and review;

6. Process improvement activities including value-based healthcare, Agile methodology, root cause analysis, statistical process control, and process mapping and reengineering;

7. Quality oversight of external sales agents/consignment models;

8. Health Authority or notified body; and

9. 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.

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
  • 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



Required Skills:



Preferred Skills:

Skills Required

  • Bachelor's degree in Engineering, Life Sciences, or a related field
  • 6 years of experience in the job offered or a related Compliance Specialist IV occupation
  • Experience with Lean management and Quality Assurance
  • Experience leading quality programs
  • Experience managing audits
  • Experience with validation and compliance
  • Experience developing, implementing, and reviewing Standard Operating Procedures
  • Experience with process improvement, including value-based healthcare, Agile methodology, root cause analysis, statistical process control, and process mapping and reengineering
  • Experience overseeing external sales agents and consignment models
  • Experience with health authorities or notified bodies
  • Experience with FDA regulations and ISO 13485 standards

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

Johnson & Johnson Insights

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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