Pubblicato il 17 giugno
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Experteer Overview
Tutte le competenze, le qualifiche e l'esperienza necessarie per un candidato di successo sono elencate nella seguente descrizione.
Regulatory Affairs Intelligence Project Manager at Enovis Recon drives compliance maturity by building and maintaining a proactive regulatory intelligence process. You will coordinate SMEs to assess regulatory and standards impacts on Recon medical devices, guide QMS updates, and communicate regulatory shifts to the business. The role supports development, submission planning, and lifecycle management in a fast-paced, global setting. Join a culture of continuous improvement and help translate regulatory insights into measurable patient outcomes.
Benefits
Establish and maintain a process to keep Recon BUs compliant with external regulations and standards
Monitor global regulatory developments and guidance from agencies (FDA, EU MDR, TGA, Health Canada, ANVISA)
Convene SMEs to analyze regulatory impacts and interpret requirements for compliance with statutory and standards bodies
Collaborate to document gap analyses and implement QMS changes to ensure ongoing compliance
Broadly communicate regulatory changes across the global business and report findings in business reviews
Provide strategic regulatory guidance across product development, submission planning, and post-market phases
Support cross-functional teams in evaluating and adapting to regulatory impacts during lifecycle management
Responsibilities
Bachelor's degree
Minimum 6 years of regulatory/medical device experience
Solid understanding of medical devices and experience in orthopedics, arthroplasty, xlwpduy and SaMD/navigation
Experience with maintaining Quality System compliance for medical solutions development and manufacturing
Ability to interpret changes, assess impact, and guide compliance processes
Experience with global Health Authorities (US FDA, EU MDR, TGA, PLAC)
Self-driven, collaborative leader capable of organizing cross-functional teams
Stro
