Ashok Kumar

I am an accomplished Regulatory Affairs professional with 7+ years of progressive experience supporting global medical device compliance across the full product lifecycle. I specialize in EU MDR 2017/745 transitions, EUDAMED data management, and successful registrations in EU, US, Canada, APAC, and LATAM markets.

I offer end-to-end regulatory support, including regulatory strategy, gap assessments, technical documentation (CER, SSCP, GSPR, risk management files), and audit-ready submissions. I have strong hands-on experience with Veeva Vault RIM, usability engineering, and lifecycle maintenance, ensuring alignment with ISO 13485, ISO 14971, EN 62366-1, and IEC 62304.

Known for optimizing regulatory timelines and maintaining effective health authority and notified body interactions, I help organizations achieve and sustain compliance efficiently and confidently.

PROFESSIONAL EXPERIENCE

CAREER HISTORY-I

Company: Alcon, Bengaluru, India 

Designation: Senior Regulatory Affairs Specialist (Associate II) – Regulatory Strategy LCM, 

Duration: May 2024 – To present

• Supported global medical device registration activities across multiple markets, including dossier preparation, regulatory application submission, registration maintenance, and creation of regulatory objectives within the Veeva RIM system
• Created and managed RIAR (Regulatory Impact Assessment Report) events for change control, conducting impact assessments, risk evaluations, and activity tracking to enable timely regulatory actions and controlled implementation of design and manufacturing changes
• Managed PSR (Product Support Request) ticketing via Power Apps for global affiliates, addressing health authority requirements including declaration letters, notary support, and Certificate of Analysis (COA) generation in SAP Logon for market-specific submissions
• Coordinated Free Sale Certificate (FSC) requests with external consultants, ensuring documentation completeness and alignment with country-specific regulatory requirements for medical device exports
• Supported EUDAMED data collection, validation, and upload activities within Veeva RIM, ensuring data integrity, completeness, and consistency for EU medical device registration and UDI requirements
• Prepared STED (Summary of Technical Documentation) for EU MDR Submissions
• Supported health authority interactions by compiling evidence-based responses to regulatory queries and coordinating with cross-functional partners (Quality, R&D, Supply Chain, Labeling) to resolve deficiencies
• Created and maintained Veeva Vault registration records for Europe, Canada, and the United States across global product codes, monitoring lifecycle changes, and implementing real-time updates
• Facilitated global Change Control execution through Veeva RIM across 184 countries, streamlining regulatory communication and ensuring timely product approval and restriction updates with logistics teams.

Key Achievements

• Designed and implemented a global RIAR follow-up workflow with advanced Excel-based trackers featuring automated formula checks, improving change control visibility, closure rates, and regulatory oversight
• Developed standardized Excel templates for global affiliates to harmonize RIAR and registration data collection, enhancing transparency, consistency, and traceability across regions
• Built robust verification workbooks to cross-check registration details, including DOC and product certificates for global registrations, enhancing data accuracy and inspection readiness

CAREER HISTORY-II

Company: Tata Elxsi, Magarpatta City, Pune, India – Medical devices

Designation: Senior Regulatory Engineer, 

Duration: May 2021 – Apr 2024

• Led MDD to EU MDR transition and DHF remediation projects, performing comprehensive gap assessments against EU MDR 2017/745 for medical devices
• Conducted detailed gap analyses for Software Requirements and Design Specifications per IEC 62304:2006 A1:2020, including software safety classification and traceability matrices from design inputs through SRS and SDS
• Analyzed and remediated FMEA (Application and Design) in alignment with ISO 14971, updating risk files, hazard identification, and control measures
• Developed Design Control Traceability Matrices and remediated Usability Engineering Plans/Reports in accordance with EN 62366-1
• Created STED and comprehensive technical documentation packages for EU MDR submissions, including labeling and IFU remediation per ISO 15223-1 and ISO 20417
• Designed gap-assessment checklists and standard repositories for IEC 62304, ISO 10993-1, ISO 11607-1, IEC 60601-1/-1-2, reducing assessment timelines.
  • Reduced regulatory standard assessment timelines from 7 to 2 business days through strategic checklist and repository optimization, achieving zero-defect density in deliverables

Key Achievements

• Enhanced team efficiency and consistency across multiple concurrent regulatory projects through standardized assessment frameworks

CAREER HISTORY-III

Company: HCL Technologies, SEZ, Madurai, India

Designation: Product Regulatory Analyst

Duration: | Apr 2019 – May 2021

• Conducted Risk Management gap analyses per ISO 14971:2019 and defined new requirements based on state-of-the-art regulatory practices
• Reviewed design inputs/outputs to identify potential hazards and supported Biological Safety Evaluations aligned with ISO 10993
• Assessed usability documentation per EN 62366-1 and evaluated Quality Management documentation per ISO 13485:2016
• Supported MDD to MDR transitions and prepared Summaries of Technical Documentation for notified body submissions under EU MDR 2017/745
• Developed regulatory assessment checklists for ASEAN, MHRA (UK), ANVISA (Brazil), PMDA (Japan), and Health Canada to support structured global submissions
• Collaborated with product development and quality teams to ensure regulatory compliance throughout the product lifecycle

Key Achievements

• Received Customer Appreciation Awards for defect-free and timely deliverables
• Recognized with "Extra Miles" Award for contributions to team management and project success
  • Reviewed Informed Consent Forms and Trial Master File data to ensure regulatory and ethical compliance for clinical studies

CAREER HISTORY-IV

Company: Micro Therapeutic Research Labs, Chennai, India

Designation: Research Analyst – Quality Control

Duration: | May 2018 – Dec 2018

• Verified Certificates of Analysis for Active Pharmaceutical Ingredients (APIs)
• Contributed to internal audits focused on process improvement and regulatory adherence
• Reviewed Informed Consent Forms and Trial Master File data to ensure regulatory and ethical compliance for clinical studies

• Bachelor of Technology in Biotechnology, 2014-2018                        

Adhiyamaan College of Engineering, Hosur, Tamil Nadu