D MANJESH

• Quality Auditing: Skilled in conducting internal and external audits to assess and improve compliance with quality and regulatory requirements.
• Design Control: Adept at managing design and development processes, including verification and validation activities, in accordance with regulatory guidelines.
• Regulatory Submissions: Skilled in preparing EU MDR Technical, CDSCO documentation, and other regulatory documents to gain market access.
• Project Management: Adept at leading cross-functional teams to drive projects related to regulatory submissions, quality improvements, and compliance initiatives.
• Post-Market Surveillance (PMS): Experienced in monitoring and reporting adverse events and product complaints, as well as implementing corrective and preventive actions (CAPA).
• Risk Management: Experienced in developing and implementing risk management strategies to ensure product safety and efficacy (ISO 14971).

Sterilization Validation – ISO 11135:2014 (EO Sterilization)

• Led EO sterilization validation for medical devices in compliance with ISO 11135:2014.
• Managed process development, OQ, PQ, and validation to ensure safety and regulatory compliance.
• Collaborated with cross-functional teams to meet ISO and EU MDR requirements.
• Oversaw routine monitoring, documentation, and requalification to maintain process efficacy.
• Analyzed biological indicators and cycle results, adjusting parameters for optimal performance.
• Biological Evaluation (ISO 10993 Compliance)
• Biological Safety Assessments: Performed ISO 10993-compliant evaluations for medical devices and materials.
• Risk Assessment and Testing: Identified biological hazards and coordinated biocompatibility testing (cytotoxicity, sensitization, irritation) with accredited labs.
• Regulatory Documentation: Prepared biological evaluation reports (BERs) for regulatory submissions in global markets.
• Gap Analysis and Compliance: Conducted gap analyses to ensure alignment with updated ISO 10993 standards.
• Material Biocompatibility: Assessed material safety during product development in line with ISO 10993-1.

• Quality Management Systems (QMS)-Proficient in establishing, maintaining, and optimizing QMS to ensure compliance with industry regulations and standards (ISO 13485)
• CAPA (Corrective and Preventive Action)- Experienced in identifying, investigating, and resolving non-conformances and implementing CAPA processes to prevent recurrence
• Good Manufacturing Practices (GMP): Knowledgeable in GMP requirements and practices for the medical device industry
• Document Control: Competent in managing document control systems, ensuring accurate and compliant documentation throughout the product lifecycle
• Change Control Management: Proficient in change control processes, including impact assessment and regulatory notification