Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations (Internal/External) and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables as per the design control procedure.
Document all new ideas for products and/or processes which should be assessed for intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement
Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles....
Communicate with Regional RA to ensure timely notification of changes as appropriate. Partner with Regional RA to support registration of product in foreign markets. Fulfill basic requests and coordinate with applicable RA staff regarding more complex requests.
Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc under supervision
Review and provide feedback to risk management assessments and design control deliverables, as necessary to ensure that it follows the regulatory requirements under supervision....