Project Manager
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New Business Acquisition I Business Expansion I Client Management I Service Extension I Post Market Surveillance I Clinical Evaluation I Medical Device I Quality Assurance & Regulatory Affairs (QARA) | Project Management
15+ Years of wide experience | Project Management | EU MDR 2017/745 | MEDDEV 2.7/1 Rev. 4 I ISO 13485 (QMS) | MDCG Guidelines I Windchill PLM I Business Proposals | Project Costing Sheet | Resource Management | New Service Offering | Business Account Mining
TATA ELXSI, Pune, India
Project Manager – Business and Delivery (PMS & Clinical evaluation)
Jun 2023 – Present
2026: Business Expansion – Exploring new business opportunities, pitching services to client, account exploration and mining, extension of new services to existing clients.
2026: EMEA PMS Project:Leading team to update PMS documents (PMSP, PMSR & PSUR) for medical device of various classes. This includes – kick off email, pulling sales data from SAP, requesting complaint data, performing IMDRF (International Medical Device Regulators Forum) analysis, preparing Annex – A, C, F & D, pulling registry data, literature search and drafting PSURs.
2026: EMEA Annual Sustenance Project: Leading team to update clinical documents for medical devices (Instrument & Implants) of various classes.
2025: Prepared client proposals, respond to RFPs, manage cost sheets &WoN allocation, and allocated resources within project budgets.
2025: Led Annual Sustenance of Medical device for BSI Submission: Led and managed clinical documents drafting and deliveries for medical devices of various classes.
2025: Led Annual Sustenance of PSUR drafting and deliveries for medical devices of various classes for Health Canada and EU market.
2024: Led clinical documents drafting and deliveries for medical devices (Instruments & Implants) of various classes.
2023: Led clinical documents drafting and deliveries for medical devices (Instruments) of various classes.
Document Authoring & Submission
Lead author for CEPs, CERs, and SSCPs in accordance with EU MDR and MEDDEV 2.7/1 Rev. 4, translating complex clinical data into robust regulatory documentation that supports global submission strategies.
Systematic Literature Review & Data Appraisal
Conduct comprehensive literature reviews and appraisals of clinical data, using platforms like PubMed, Embase, and Google Scholar to gather and analyze the latest evidence supporting the safety and effectiveness of medical devices.
Synthesize findings into clear benefit-risk profiles and justifications, directly supporting regulatory decisions and sponsor submissions.
Regulatory Strategy & Process Optimization
Ensure all clinical evaluation activities are compliant with global and local regulatory requirements, optimizing documentation strategies for successful, audit-ready submissions.
Oversee versioning and lifecycle management of clinical documents, ensuring up-to-date and accessible records throughout the project.
Cross-Departmental Alignment
Work closely with quality assurance, regulatory affairs, and product development teams to ensure clinical evaluation aligns with broader organizational and product strategies, maintaining consistent compliance and scientific rigor.
MYLAN RESEARCH LABORATORIES, Ahmedabad, India
Deputy General Manager (Oct 2014 – Mar 2017)
Managed cross-functional project portfolios including regulatory and clinical submissions.
Oversaw vendor communications, budget tracking, and project delivery.
Contributed to product development documentation and ensured compliance with regulatory authority expectations.
ZYDUS RESEARCH CENTRE, Ahmedabad, India
Project Manager & Associate Research Sci. – Toxicology (Aug 2004 – Dec 2013)
Led toxicology studies across species per OECD GLP for regulatory safety submissions.
Managed team planning, resource allocation, and documentation for preclinical development programs.
Ensured compliance with quality and regulatory systems in all study phases.
TORRENT RESEARCH CENTRE, Ahmedabad, India
Toxicology Research Assistant (Aug 2002 – Jul 2004)
Executed toxicology studies in accordance with Netherlands GLP.
Supported safety assessments and report generation for preclinical programs.
Participated in cross-functional reviews and risk assessments.
