Alexes Gonzalez

Sr Regulatory Affairs Specialist (Franchise Lead) @Candela Medical

US

Regulatory Franchise Lead for 3 class II medical devices for EU, Canada, Australia and USA (Vbeam and Gentle series product lines)• Support business growth by developing go-to-market strategies for NPI and LCE projects; execute applicable registrations and action plans on time per project deadlines.• Represent regulatory on multidisciplinary teams and communicate regulatory requirements effectively to cross-functional peers (e.g, clinical, global business unit, project management, quality).• Track submission review progress with related authorities (e.g, FDA) and work closely with relevant departments (internal and external) to drive reduction of submission review and approval cycle time.• Conduct appropriate research to develop strong, risk-based regulatory strategies for new products.• Identify potential regulatory risks and advise business of upcoming changes in product regulations; assist in countermeasure development and implementation to ensure quick adaption to the new regulations.• Maintain knowledge and understanding of global regulatory requirements with an emphasis on US, EU, and Canada, and provide expertise in translating regulatory requirements into practical and workable plans.• Evaluate regulatory impact of proposed design and manufacturing changes.• Review and approve all labeling (product, advertising and promotional).