Regulatory Affairs Specialist

Responsibilities

• Managed regulatory submissions (510k, PMA) for IVD products, including preparation and submission of documentation, developed and executed regulatory strategies to facilitate product registrations and listings.
• Reviewed and approved Technical File and PMS documents in accordance with EUMDR before release, ensuring completeness, and compliance with regulatory guidelines.
• Managed and maintained STED Technical files, facilitated CE marking and notified body interactions for EU/MDR compliance across IVD, class II, III, and combinational devices, handled MDR compliant technical files.
• Conducted Design plan Regulatory assessments, implemented Project Management Techniques to monitor regulatory projects, ensuring coordination for regulatory compliance and efficacy in product lifecycle planning.
• Involved in transitioning of MDD Technical Files according to the updated EU MDR guidelines and performed GAP Analysis on the according to the EU regulations.  
• Conducted investigations into regulatory and trade issues, provided regulatory input to mitigate risks and facilitate compliance with regional regulatory requirements.
• Managed regulatory aspects of product recalls, regulatory history and submission processes, collaborated with cross-functional teams to review change controls, ensuring regulatory compliance.
• Developed and executed regulatory filing strategies for medical products, ensuring timely submission and approval of regulatory documents for new registrations and product post marketing approval.
• Prepared and submitted 510k regulatory documentation for regulatory approvals, adhering to submission requirements and maintained compliance with regulatory guidelines.
• Developed and maintained SOPs related to regulatory affairs, ensuring consistency and adherence to regulatory standards across organization.
• Involved in regulatory review of clinical and manufacturing changes, ensuring alignment with GxPs, GMPs, GLPs, and relevant regulatory standards.
• Provided regulatory input on label development, ensuring adherence to regional labeling requirements and facilitating product release, conducting risk analysis for regulatory initiatives. 
• Managed integration of regulatory considerations into manufacturing processes, facilitated regulatory approvals for manufacturing changes.
• Supported deficiency rounds for MDR TD submission, submitted MDR Technical files to GMED, managed Change requests, renewed Health Canada license for 2023, evaluated COs and CRQs for ongoing compliance with evolving regulations.