• Ensure compliance with global medical device regulations throughout the product lifecycle • Develop and execute regulatory strategies • Prepare and submit documentation to regulatory authorities • Maintain adherence to standards such as FDA, EU MDR, and ISO 13485 • Collaborate with cross-functional teams to support product development, labeling, marketing, and post-market activities • Monitor regulatory changes and ensure timely implementation of projects • Interface with regulatory agencies (e.g., FDA, Notified Bodies) and respond to inquiries • Provide regulatory input to support product labeling and promotional materials • Lead corrective and preventive action (CAPA) efforts as assigned • Serve as regulatory lead on product development teams • Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions • Assess regulatory impact of product changes and provide guidance to cross-functional teams • Advice on regulatory requirements during design, development, and commercialization phases • Assess and document regulatory impacts of design changes, manufacturing changes, etc. • Support and participate in internal and external audits and regulatory agency inspections • Complete QMS training activities and provide regulatory expertise to continuous improvement activities • Support Lean and Kaizen initiatives • Comply with all company policies and procedures