Director, Loaner Licensure

Johnson & Johnson

Director, Loaner Licensure leading global quality and regulatory processes at DePuy Synthes. Ensuring compliance and effectiveness in loaner instrument programs and licensure activities.

Posted 6/8/2026full-timeNew Brunswick • New Jersey • 🇺🇸 United StatesLead💰 $150,000 - $300,000 per yearWebsite

About the role

Key responsibilities & impact

Provide strategic and operational leadership for global Loaner, Licensure, and FSN quality processes, ensuring compliance with applicable regulations and internal quality standards.
Own and continuously improve quality system elements supporting loaner instrumentation lifecycle management, regulatory licensure maintenance, and execution of Field Safety Notices.
Lead cross – functional governance for FSN decision – making , execution, documentation, and health authority communications in partnership with Regulatory Affairs.
Ensure inspection readiness and serve as a senior quality representative during regulatory inspections, audits, and health authority interactions related to loaners, licensure, and FSNs.
Develop, implement, and monitor global policies, procedures, and controls to ensure consistent compliance across regions and operating companies.
Assess quality and regulatory risks; drive proactive risk management, CAPA, and continuous improvement initiatives.
Build, lead, and develop a high – performing team, fostering a culture of quality, accountability, and continuous improvement.
Partner with senior leaders to align quality strategy with business objectives and evolving global regulatory requirements.

Requirements

What you’ll need

Bachelor’s degree required (Engineering, Life Sciences, Regulatory Affairs, or related field).
Advanced degree (Master’s, MBA, or equivalent) preferred.
Typically 10–12 years of progressive experience in Quality, Regulatory Affairs, or Compliance within a medical device or regulated healthcare environment.
Demonstrated leadership experience at the Director or senior management level, including people leadership and matrixed team influence.
Strong working knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).
Proven experience leading complex quality system processes such as recalls, FSNs, regulatory submissions/licensure, or post – market quality activities.
Experience partnering with cross – functional stakeholders and influencing senior leadership.
Preferred: Experience specifically supporting loaner instrument programs and global distribution models.
Direct involvement in global FSN or recall governance and execution.
Experience operating in a global, matrixed MedTech organization.
Track record of driving large – scale process improvement and transformation initiatives.
Familiarity with digital quality systems and data – driven compliance monitoring.
Excellent written and verbal communication skills, including interaction with regulatory authorities.
English required ; additional languages a plus.

Benefits

Comp & perks

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Hard Skills & Tools

quality system managementregulatory compliancerisk managementCAPAprocess improvementmedical device regulationsregulatory submissionspost-market quality activitiesglobal distribution modelsdigital quality systems

Soft Skills

leadershipteam developmentcross-functional collaborationinfluencing senior leadershipcommunicationaccountabilitystrategic alignmentoperational leadershipproblem-solvingcontinuous improvement