Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:Professional
All Job Posting Locations:Raynham, Massachusetts, 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(n) Manager, Integration, Depl. Sys. & Dev, Regulatory - Other, located in Raynham, Massachusetts, West Chester, PA, Warsaw, IN, Palm Beach Gardens, FL or NJ.
The Manager, Integration, Deployment Systems & Development is responsible for leading regulatory-related system integration, deployment, and development activities that support compliant business operations. This role plays a critical part in ensuring regulatory processes, data, and tools are effectively integrated, deployed, and maintained to meet evolving regulatory requirements. The position partners closely with Regulatory Affairs, Quality, IT, and business stakeholders to enable scalable, compliant, and efficient regulatory systems and solutions across the organization.
Key Responsibilities
- Lead and manage regulatory system integration, deployment, and development initiatives in alignment with regulatory and compliance requirements.
- Partner with Regulatory Affairs, Quality, IT, and business teams to define system requirements and ensure compliant implementation.
- Support deployment and ongoing enhancement of regulatory systems and tools, ensuring data integrity and usability.
- Oversee change management activities related to regulatory system updates, integrations, and enhancements.
- Ensure regulatory system processes align with internal policies, quality system requirements, and applicable regulations.
- Support audits, inspections, and assessments related to regulatory systems and data.
- Monitor regulatory and system-related changes and assess impacts to tools, processes, and integrations.
- Drive continuous improvement initiatives to enhance regulatory system efficiency, scalability, and compliance.
Qualifications
Education:
- Bachelor's degree in Regulatory Affairs, Information Systems, Engineering, Life Sciences, or a related discipline (required).
- Advanced degree or professional certification in Regulatory Affairs, Information Systems, or related fields (preferred).
Experience and Skills:
Required:
- Typically 6-8 years of progressive experience in regulatory systems, regulatory operations, IT systems integration, or a related role within a regulated industry.
- Experience supporting system integration, deployment, or development initiatives in a compliance-driven environment.
- Strong understanding of regulatory processes and data requirements.
- Ability to translate regulatory and business requirements into system solutions.
Preferred:
- Experience in medical devices, healthcare, or other highly regulated industries.
- Familiarity with regulatory information management (RIM) systems or related platforms.
- Experience supporting audits or inspections involving regulatory systems.
- Experience working in a global or matrixed organization.
- Demonstrated experience driving system or process improvement initiatives.
- Effective written and verbal communication skills.
- Strong project management, problem-solving, and stakeholder management skills.
Other:
- Language: English required.
- Travel: Limited; occasional domestic or international travel as needed.
- Certifications: Regulatory Affairs Certification (RAC) or relevant systems/project 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.
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.
#LI-Hybrid
#DePuySynthesCareers
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)).
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
