Koushik Nath

Regulatory Affairs & Quality Assurance Leader with 16 years' experience, including 12 years in the medical device domain. Expert in global regulations (MDSAP, IMDRF, US FDA 21 CFR 820, EU MDR 2017/745) and standards (ISO 9001:2015, ISO 13485:2016) with strong post-market expertise in complaint handling, CAPA, recalls, FSCA, PSUR, and audit readiness. Skilled in pre-market submissions (510(k), PMA, CE Marking) ensuring compliance and market access.

Recognized for strategic leadership, Lean Six Sigma Black Belt proficiency, operational excellence, AI/ML-driven automation, and cross-functional collaboration across diverse portfolios including orthopaedic, cardiovascular, surgical, diagnostic, and robotic systems — driving compliance, patient safety, and growth.

Senior MDR Vigilance Specialist - Medtronic Inc.

• Medtronic Engineering and Innovation Center – Hyderabad

(2022-02)

• Managed global medical device complaints end-to-end — from intake and GFEs through investigation, risk assessment, and root cause analysis. Ensured accurate regulatory decisions and timely reporting to US FDA (Form 3500A/eMDR), Health Canada, TGA, PMDA, NMPA, CDSCO, and EU Notified Bodies, with IMDRF code assignment and PSUR integration. Executed CAPA, closed complaints with audit-ready documentation, and performed trending/signal detection to support recalls and FSCA — driving compliance, patie
• Drove continuous improvement and innovation by collaborating with cross-functional teams to identify, prioritize, and implement process enhancements across products and services; leveraged Artificial Intelligence and Machine Learning–based automation to improve efficiency, reduce operational risk, and increase productivity.
• Led planning, tracking, and allocation of daily work to manage work-in-progress and ensure timely delivery of quality and regulatory activities including MDSAP; oversaw end-to-end compliance operations including audits, CAPA management, remediation actions, field corrective actions, recalls, and trend analysis, ensuring audit readiness, timely closure of quality issues, effective risk mitigation, and sustained regulatory compliance.
• Triggered timely change notifications and supported change management processes to ensure work instructions and SOPs were proactively updated in line with evolving regulatory requirements and standards including EU MDR 2017/745, 21 CFR, IMDRF coding, and ISO 13485:2016, ensuring sustained compliance, minimized regulatory risk, and maintained audit readiness.

Deputy Manager (Merge Healthcare) - Wipro Ltd.

• Kolkata

(2021-01 - 2022-02)

• Led and mentored engineering teams to deliver medical device Regulatory Compliance and Post Market Surveillance projects aligned with client expectations, contractual commitments, and quality standards.
• Directed end-to-end medical device complaint handling, overseeing complaint intake, investigation, and regulatory reporting teams ensuring timely complaint handling, Good Faith Efforts (GFEs), regulatory decisions, FDA Form 3500A/MIR reporting, risk assessment, root cause determination, FDA/IMDRF code assignment, and submission of regulatory reports and PSURs in compliance with global requirements.
• Supported risk assessment activities, Quality Management System (ISO 13485:2016) documentation, and 510K submissions; managed external audits by FDA, EEA Notified Bodies, and ISO certification bodies with outcomes of no nonconformities, and conducted internal quality audits to ensure compliance with corporate standards, regulatory requirements, and QMS processes.
• Established training frameworks and optimized resource allocation to align team capabilities with project requirements, drive continuous skill development, and maintain compliance with evolving standards.
• Oversaw team performance, employee development, engagement, training, recruitment, and change management to build high-performing teams and maintain workforce stability.
• Partnered with stakeholders for project planning, cost estimation, budget management, and resource optimization.
• Managed client relationships through expectation alignment, effective communication, and timely delivery of high-quality outcomes; collaborated cross-functionally and partnered with key stakeholders to identify client pain points, analyze business needs, and develop a strategic pipeline of high-impact projects, evaluating opportunities, prioritizing initiatives based on business value, and supporting future project planning to improve client outcomes and drive business growth.

Tech-Lead (C.R Bard/CareFusion/BD) - HCLTech Ltd.

• Chennai

(2019-04 - 2021-01)

• Led and mentored engineering teams to deliver medical device Regulatory Compliance and Post Market Surveillance projects aligned with client expectations, contractual commitments, and quality standards; optimized resource allocation, team capabilities, performance, recruitment, training, engagement, and change management to build high-performing, sustainable teams.
• Directed end-to-end medical device complaint handling, overseeing complaint intake, investigation, and regulatory reporting teams ensuring timely complaint handling, Good Faith Efforts (GFEs), regulatory decisions, FDA Form 3500A/MIR reporting, risk assessment, root cause determination, FDA/IMDRF code assignment, and submission of regulatory reports and PSURs in compliance with global requirements.
• Supported CE Marking team in managing end-to-end EU MDR compliance activities including device classification, GSPR assessment, QMS and risk management requirements, Technical Documentation, clinical evaluation, conformity assessment, Notified Body coordination, EU Authorized Representative requirements, UDI/EUDAMED registration, EU Declaration of Conformity, and CE Marking; provided regulatory direction to ensure timely certification, maintenance of compliance, and effective execution of CE Mar
• Supported external and internal audits conducted by the U.S. FDA, EEA Notified Bodies, and ISO certification bodies, consistently achieving zero nonconformities; ensured audit readiness, timely CAPA closure, effective quality governance, and compliance oversight while strengthening client relationships, stakeholder expectations, communication, and delivery of high-quality outcomes.
• Directed Product Recall and Field Safety Corrective Action (FSCA) initiatives, ensuring timely execution, regulatory compliance, effective risk mitigation, and seamless cross-functional coordination to protect patient safety and maintain business continuity; collaborated with stakeholders to identify client pain points, analyse business needs, and develop a strategic pipeline of high-impact projects aligned with organizational goals to improve client outcomes and drive business growth.

Reliability Engineer (Contract) - Stryker Corporation - Gurgaon

(2014-05 - 2019-04)

Stryker Global Technology Center R&D – Gurgaon (Contract). May'2014 – Dec'2016: IQuest Management Solutions Pvt Ltd: Reliability Engineer. (Payroll). Jan'2017 – Mar'2019: Kritikal Solutions Pvt.

Ltd: Reliability Engineer. (Payroll).

• Managed global medical device complaints end-to-end — from intake and GFEs through investigation, risk assessment, and root cause analysis. Ensured accurate regulatory decisions and timely reporting to US FDA (Form 3500A/eMDR), Health Canada, TGA, PMDA, NMPA, CDSCO, and EU Notified Bodies, with PSUR integration.
• Collaborated with global cross-functional teams (Quality, Regulatory, Manufacturing, Clinical, Design, Legal, CAPA, Customer) to drive investigations, data collection, complaint closure, and corrective action decisions; analysed complaint trends and quality signals to support escalations.
• Supported external and internal audits conducted by the U.S. FDA, EEA Notified Bodies, and ISO certification bodies, achieving outcomes with no nonconformities; contributed to continuous compliance, CAPA implementation, PSUR activities, periodic complaint trending, quality system improvements, and Product recalls/Field Corrective Actions (FCA).
• Performed comprehensive medical device risk assessments using FMEA and FTA to identify hazards, failure modes, and risks, establish effective risk control measures, support root cause analysis, and ensure compliance with ISO 13485, ISO 14971, regulatory requirements, and medical device quality standards.

ISO Auditor Trainee - KVQA, ISO Certifications - Noida

(2013-02 - 2014-04)

• Assisted Lead Auditors in conducting ISO certification and surveillance audits for ISO 9001, ISO 14001, OHSAS 18001, ISO 13485, and TS 16949 across more than 100 organizations, ensuring compliance with applicable standards and certification requirements.
• Conducted ISO management system gap assessments and compliance reviews across client organizations, evaluating Quality Manuals, policies, SOPs, procedures, records, risk assessments, and process documentation to identify nonconformities, assess process effectiveness, and support continual improvement of management systems.
• Supported organizations in establishing ISO-compliant frameworks through process development, internal auditor training, employee awareness programs, risk management practices, and implementation of quality records and controls.
• Evaluated CAPA effectiveness for identified nonconformities and provided recommendations to strengthen corrective actions, prevent recurrence, and improve system effectiveness.
• Verified process-based management system implementation, including work instructions, records, policies, prerequisite programs, critical control points, and operational controls, ensuring alignment with applicable ISO requirements.

Quality Assurance Supervisor - Nextgen Printers Pvt. Ltd.

• Sikkim

(2010-01 - 2013-02)

• Led QA teams in managing mono carton packaging operations for pharmaceutical clients by enhancing technical capabilities, accountability, and a culture of continuous improvement; conducted quality training and awareness programs to strengthen compliance with pharma packaging standards and operational excellence.
• Implemented Lean and Total Quality Management (TQM) practices to improve process efficiency and packaging quality; managed client complaints related to packaging materials, performed Root Cause Analysis (RCA), and implemented corrective actions to prevent recurrence in pharma supply chains.
• Conducted internal ISO audits and Management Review Meetings (MRM) focused on compliance; maintained ISO documentation, SOPs, GMP practices, preventive maintenance, and safety systems specific to mono carton packaging for pharma products.
• Reviewed Certificates of Analysis (COA), Acceptance Quality Level (AQL) results, and inspection records of mono carton packaging materials to ensure product conformity, regulatory compliance, and adherence to stringent pharmaceutical client quality standards.

Bachelor of Technology - Mechanical Engineering - Sikkim Manipal Institute of Technology