Project Mgr, Business Product & Dev

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.