- Prepare pre-market submission reports and technical files for FDA, Health Canada, EU, APAC, and Middle East agencies.
- Manage international product registrations, license renewals, and registration amendments including FDA 510(k)s and EU MDR Technical Documentation.
- Review and interpret FDA and international regulations to ensure sound product submissions.
- Conduct regulatory review of post-market product changes and determine appropriate change control mechanisms.
- Assess new market opportunities by determining classification, registration pathways, and providing strategy for product launches.
- Support Notified Body and international regulatory inspections and audits.
- Monitor global regulatory evolutions to assess and communicate business impact to stakeholders.
- Prepare and manage export documentation including Certificates to Foreign Government and Declarations of Conformity.