●     Develop and implement strategies to ensure compliance with global government regulatory bodies, including FDA, EMA, , TGA, ANVISA, MDSAP, HSA,  PMDA, and EU notifying and competent Authorities .
●     Serve as the liaison between regulatory bodies and operating divisions, ensuring effective communication and compliance with regulations.
●     Prepare and submit applications and reports to applicable regulatory agencies in a timely and accurate manner.
●     Respond to requests for information from regulatory bodies, providing comprehensive and compliant responses.
●     Coordinate with operations departments to ensure compliance with regulations during production design and development processes.
●     Assist in the development of standards for the company\'s operating and production procedures, ensuring alignment with regulatory requirements.
●     Maintain up-to-date knowledge of regulations applicable to the company and monitor changes that may impact company operations.
●     Develop and maintain professional relationships with federal, state, and local regulatory agencies.
●     Coordinate and maintain UDI and BUDI compliance.
●     Perform other related duties as assigned.
Key Achievements:
●     Expanded the Quality Management System (QMS) to support international requirements, leading to ISO13485 and MDSAP certification.
●     Created a custom quality tool to conduct a comprehensive QMS gap assessment, covering MDSAP, ISO13485, QSR, and ISO9001.
●     Successfully created and submitted regulatory files for FDA 510k and CE Marking (EU), for more than ten products ensuring compliance with regulatory requirements.
●     Implemented an effective Corrective & Preventive Action (CAPA) system, post-market surveillance, and investigation processes in accordance with 21CFR820.100.

●     Consult with stakeholders to implement processes and procedures and conduct analyses to sustain and improve regulatory processes, consistently striving for comprehensive and complete solutions while minimizing the time to market .
●     Develop regulatory strategies (including determining the correct classification, identifying regulatory requirements, or selecting the best approval pathway) .
●     Prepare and/or review regulatory submissions .
●     Develop audit plans, inspection methods, and procedure development .
●     Define post-market plans and activities including complaint handling, MDR and IVDR evaluations, and CAPA assessments .
●     Project manage regulatory projects for domestic and international medical device companies including FDA submissions (510(k), PMA, De Novo) and Technical Documentation/CE Mark submissions (EU MDR/ EU IVDR) .
●     Serve as Subject Matter Expert (SME) offering strategic direction and tactical support to company in the international registration and approval of medical devices .
●     Communicate with Regulatory authorities and Notified Bodies .
●     Work with suppliers, regulatory agencies, clients, and other group members to assist with implementation and effectiveness of client deliverables .
●     Review project plans, data, procedures, and test protocols/reports for accuracy and technical application of standards (ISO, AAMI, ASTM, IEC) .
Key Achievements:
Get Product FDA 510k 
Get TGA and Health Canada approval 
develop MDSAP requirements 

●     Coordinated with cross-functional teams to ensure compliance with regulatory requirements during product design and development stages.
●     Led the regulatory assessment and provided guidance on the regulatory pathways for new product lines in domestic and international markets.
●     Conducted thorough regulatory research to stay up-to-date with changing regulations and effectively communicated the impact of these changes on company operations.
●     Prepared and maintained regulatory documentation, including technical files and regulatory submissions, ensuring adherence to applicable regulations and standards.
●     Played a key role in designing and implementing a comprehensive quality management system (QMS) that led to ISO13485 certification

●     Developed and implemented strategies to ensure compliance with global government regulations, including FDA, EMA, and TGA.
●     Led a team of regulatory professionals in preparing and submitting applications and reports to regulatory agencies.
●     Successfully obtained FDA approval and CE Marking for multiple medical devices, demonstrating a deep understanding of the regulatory filing process.
Played a key role in designing and implementing a comprehensive quality management system (QMS) that led to ISO13485 certification