Project Mgr, Business Product & Dev

Johnson & Johnson is separating its Orthopaedics business to establish a standalone orthopaedics company, DePuy Synthes. This role is part of that transition; upon completion of the separation, employment will transfer to DePuy Synthes with updated processes, policies, and benefits.

About the role

The Project Manager, Business Product & Development plans, coordinates, and executes regulatory-related business product and development initiatives. This role supports compliant, scalable regulatory solutions by partnering across Regulatory Affairs, Quality, IT, and business teams to enable regulatory readiness, process improvement, and operational efficiency in a regulated MedTech environment.

The position collaborates with Regulatory Affairs and IT to translate business requirements into application functional specifications, leading the design, development, and launch of new features, capabilities, and enhancements within the Regulatory Operations System portfolio. The role also utilizes Process Excellence tools to standardize and streamline processes and partners with business unit leaders and subject matter experts to drive continuous improvement.

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.

Requirements

• Bachelor’s degree in Business, Regulatory Affairs, Life Sciences, Engineering, Information Systems, or a related discipline (required).
• Advanced degree or project management certification (preferred).
• 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 Qualifications

• 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.

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

Pay

The anticipated base pay range for this position is $109,000.00 - $174,800.00.

Schedule

• Limited travel; occasional domestic travel required.

English language proficiency is required.