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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
Job Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes is recruiting for a Manager, License, Data, & Quality (LDQ), located in Raynham, Massachusetts. West Chester, PA, Warsaw, IN, Palm Beach Gardens, FL or NJ.
**Job Overview **
The Manager, License, Data, & Quality (LDQ) is responsible for leading regulatory license management, data governance, and quality‑related activities to support compliant product lifecycle management. This role ensures the accuracy, integrity, and availability of regulatory data and licenses while strengthening quality and compliance frameworks. The position plays a key role in enabling regulatory readiness, audit support, and effective decision‑making by partnering closely with Regulatory Affairs, Quality, IT, and business stakeholders across the organization.
**Key Responsibilities **
- Lead and manage regulatory license, data, and quality (LDQ) activities to ensure compliance with applicable regulations and internal standards.
- Oversee regulatory license management processes, including tracking, maintenance, and renewals.
- Ensure accuracy, completeness, and integrity of regulatory data across systems and repositories.
- Partner with Regulatory Affairs, Quality, IT, and business teams to align data and quality requirements with regulatory needs.
- Support regulatory inspections, audits, and internal assessments related to licenses, data, and quality records.
- Monitor changes in regulatory and data governance requirements and assess impacts to processes and systems.
- Develop and maintain procedures, guidance, and training related to LDQ processes.
- Drive continuous improvement initiatives to enhance regulatory data quality, compliance, and operational efficiency.
**Qualifications **
**Education: **
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Information Management, Quality, or a related discipline (required).
- Advanced degree or professional certification in Regulatory Affairs, Quality, or Data Management (preferred).
- Experience and Skills:
**Required: **
- Typically 6-8 years of progressive experience in regulatory operations, license management, data governance, or quality compliance within a regulated industry.
- Experience managing regulatory licenses, records, or registrations across product lifecycles.
- Strong understanding of regulatory data and quality requirements.
- Ability to interpret regulatory requirements and translate them into operational processes.
- Strong attention to detail and ability to manage complex data sets and documentation.
**Preferred: **
- Experience in medical devices, healthcare, or other highly regulated industries.
- Familiarity with regulatory information management (RIM) systems.
- Experience supporting regulatory audits or inspections.
- Experience working in a global or matrixed organization.
- Demonstrated experience driving regulatory data or quality process improvements.
- Effective stakeholder management, communication, and collaboration skills.
**Other: **
- Language: English required.
- Travel: Limited; occasional domestic or international travel.
- Certifications: RAC or relevant quality/data certifications preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits