Regulatory Affairs Executive
Summary
Oversee global medical device regulatory submissions, renewals, and compliance documentation for markets outside Europe/EEA/MDSAP, ensuring adherence to ISO 13485, 21 CFR Part 820, and MDR standards.
- Manage and handle the registration, renewal, change notification and local notification activities of worldwide markets until completion, except Europe / EEA / EU and MDSAP countries. Additional countries/territories may be added if new markets are opened for registration.
- Manage the application of Free Sales Certificate (FSC) and/or Certificate to Foreign Government (CFG) of the assigned markets for registration and renewal activities.
- Manage and coordinate the external apostille and legalization process of documents needed for registration, renewal, change notification and for other purposes.
- Manage the documentation of Post-market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR) of Bioptimal’s products according to frequencies in the PMS Plans.
- Provides internal audit, customer audit and certification/surveillance audit support according to the scope and frequency in the Audit Agenda/Plan.
- Maintains the documentation and compliance of the Essential Requirements (ER) documents and dossiers of Bioptimal’s MDD legacy devices.
- Maintains the documentation and compliance of Regulatory Affairs (RA) procedures, work instructions and other forms of documentation according to SAC/EN ISO 13485, MDSAP, 21 CFR Part 820 QSR and MDD/MDR requirements.
- Provides support for the MDR Technical Documentations including the creation of MDR technical reports.
- Provides support on ad hoc tasks as may be assigned by the superior from time to time