Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions. Develops and implements...
Provides leadership role on championing departmental or cross-functional engineering initiatives. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Proactively investigates, identifies, and implements best-in-class Quality Engineering...
Support the execution and documentation of Design Validation & Verification and Usability activities. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Work within a cross-functional...
About the role:The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring...
Support the development of the overall digital strategy, including CRM (email, text), web, SEO/SEM, and other key digital channels, in alignment with the broader Customer Engagement and Activation (CE&A) team...
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions. Develops and implements...