Sirtex requires regulatory compliance to various global markets. The Regulatory Compliance Manager will be responsible for the overall management of global post market compliance. These include but are not limited to post-market surveillance, vigilance activities, adverse event filing, post-market product/process changes. This person is also responsible for regulatory operations and management of global registrations. This position will be hybrid (Woburn location) or remote.PRIMARY RESPONSIBILITIES:· Management and execution of post market compliance to various regulations such as EU MDR, Health Canada Medical Device Regulations, relevant US FDA regulations, Australian TGA requirements and other relevant global market regulations.· Manage and execute review of events to determine complaint and reportability status. Complete applicable regulatory reporting as required by Regulatory agencies.· Manage and execute vigilance activities.· Maintain and manage various post market surveillance reports.· Provide regulatory guidance to cross functional teams to ensure the documents the team develops will meet the needs of the regulatory submissions.· Maintain and manage global regulatory approvals and licenses by working across the Regulatory department to ensure ownership and accountability of any required submissions (new and renewals).· Work across the Regulatory Department to establish and maintain regulatory tracker to various regulatory submissions, reporting responsibilities; communicate status to management on a periodic basis.· Work with management to determine global registration priorities and resources for new product introduction.· As required, approve advertising and promotional material and provide guidance and education to cross functional teams regarding promotional and advertising regulatory updates and climate.· Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards.· Participate in regulatory inspections as required.· Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
