Regulatory Affairs Associate

Title: Regulatory Affairs Associate Reporting to: Regulatory Affairs Manager Location: Boston, Massachusetts, USA We are seeking a highly motivated and results-drivenRegulatory Affairs Associateto join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed. This role is responsible for executing regulatory strategies, preparing and submitting regulatory documents, and providing guidance and support to cross-functional teams on regulatory matters related to global markets. Responsibilities: Execute regulatory strategies to support the registration and commercialization of medical devices in compliance with global regulatory requirements. Prepare and submit regulatory documents, including technical files, design dossiers, and other regulatory filings as required for countries outside the United States. Coordinate with in-country regulatory partners and consultants to ensure that all local regulatory requirements are met and all registrations are maintained in good standing. Provide guidance and support to cross-functional teams on regulatory matters related to global markets. Stay up-to-date with changes in global regulatory requirements and industry standards, and communicate these changes to the organization. Ensure that all regulatory submissions are of high quality, complete, and timely. Maintain knowl