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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
People Leader
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 Project Manager, Business Product & Development, located in Raynham, Massachusetts, United States, West Chester, PA, Warsaw, IN, Palm Beach Gardens or FL, or NJ
The Project Manager, Business Product & Development is responsible for planning, coordinating, and executing regulatory‑related business product and development initiatives. This role supports the delivery of compliant, scalable regulatory solutions by partnering across Regulatory Affairs, Quality, IT, and business teams. The position plays an important role in enabling regulatory readiness, process improvement, and operational efficiency while supporting business priorities in a regulated MedTech environment. The role will collaborate with both Regulatory Affairs and IT partners to translate business requirements into application functional specs in the development of innovative solutions.
The project manager leads the design, development and launch of new features, capabilities, and enhancements within existing applications or in the development of new applications within the Regulatory Operations System team portfolio. In this role will utilize Process Excellence tools and methodologies to standardize and streamline processes and partner closely with RA business unit and regional leaders and SMEs (Subject Matter Expert) to foster continued process improvement.
**Key Responsibilities **
Lead and manage regulatory business product and development projects from initiation through delivery, ensuring alignment with regulatory and business requirements.
Develop and maintain project plans, timelines, milestones, and status reporting for assigned initiatives.
Partner with Regulatory Affairs, Quality, IT, and business stakeholders to define requirements and deliver compliant solutions.
Coordinate cross‑functional teams to ensure timely execution and resolution of risks and issues.
Support implementation and deployment of regulatory business products, tools, or process enhancements.
Monitor project performance and ensure adherence to internal policies, quality system requirements, and regulatory standards.
Prepare project documentation, dashboards, and communications for stakeholders and leadership.
Contribute to continuous improvement initiatives to enhance regulatory project delivery and operational effectiveness.
**Qualifications **
Education:
Bachelor’s degree in Business, Regulatory Affairs, Life Sciences, Engineering, Information Systems, or a related discipline (required).
Advanced degree or project management certification (preferred).
**Experience and Skills: **
Required:
Typically 4-6 years of progressive experience in project management, business product development, or regulatory operations within a regulated industry.
Experience managing cross‑functional projects in a compliance‑driven environment.
Strong understanding of project management methodologies and tools.
Ability to translate regulatory or business requirements into actionable project plans.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with regulatory processes or regulatory systems and tools.
Experience supporting system implementations or process transformation initiatives.
Experience working in a global or matrixed organization.
PMP, PRINCE2, or similar project management certification.
Strong organizational, problem‑solving, and stakeholder management skills.
Effective written and verbal communication skills.
Other:
Language: English required.
Travel: Limited; occasional domestic travel.
Certifications: Project management 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 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Communication, Developing Others, Inclusive Leadership, Innovation, Leadership, Legal Support, Operational Excellence, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
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