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Principal Scientist, Instructions for Use (IFU) Strategy Lead — join J&J Family of Companies in Frazer, Chester County to shape how millions of patients and healthcare providers interact with medical innovations. This full-time position leads the strategic direction of Instructions for Use documentation and compliance frameworks across our portfolio of transformative healthcare solutions. About the Role As Principal Scientist and IFU Strategy Lead, you will drive the evolution of Instructions for Use standards, policies, and best practices across J&J's Innovative Medicine and MedTech divisions. You'll establish thought leadership in IFU strategy, ensuring that our documentation meets the highest regulatory standards while remaining clear and actionable for end users—patients, physicians, and healthcare providers worldwide. What You'll Do Develop and refine enterprise-wide IFU strategy, standards, and governance frameworks Lead cross-functional teams across regulatory affairs, clinical, product development, and quality functions Ensure IFU documentation meets FDA, international regulatory bodies, and accessibility requirements Champion innovation in user experience and clarity within regulatory constraints Mentor and guide IFU professionals across the organization Conduct and sponsor research on IFU effectiveness and patient/provider usability Collaborate with Innovative Medicine and MedTech leadership on strategic initiatives What We're Looking For Advanced degree in a scientific, technical, or healthcare-related field Minimum 10+ years in pharmaceutical, medical device, or healthcare industry Demonstrated expertise in regulatory affairs, IFU development, or technical documentation strategy Deep knowledge of FDA regulations, ISO standards, and global compliance requirements Proven leadership experience directing cross-functional initiatives Excellent written and verbal communication skills Strategic mindset with ability to influence at senior levels About J&J Family of Companies J&J is committed to advancing global health by preventing and treating serious diseases through breakthroughs in Innovative Medicine and MedTech. Our mission drives us to create solutions that improve how patients experience care and how healthcare providers deliver treatment. How to Apply Apply through this job listing to be considered for this opportunity at J&J's Frazer, Chester County location.
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