Regulatory Affairs Program Manager

Executes the regulatory strategy for obtaining registration approval of Intuitive's portfolio, according to plan. With limited supervision, coordinate with related cross functional teams to compile regulatory documentation for submission to regulatory authorities, maintenance of licenses and change management. Evaluates medical device changes, determines and executes regulatory strategy and ensures compliance. Leads advocacy effort across applicable product regulations, environment management regulations and standards related activities with relevant regulators and Government bodies. Main activities Works with cross functional teams and business teams to execute regulatory plans for medical device registrations for India. Should be knowledgeable and have experience with medical device regulations India, including requirements for approval, change management and license renewals and compiles high quality submissions in compliance with technical requirements from regulatory authorities.