Regulatory Strategy
Impact assessments, gap analysis, lifecycle changes, global registrations, regulatory intelligence.
Regulatory Affairs · Medical Devices · Biopharma
Alifiya
Parekh
I turn complex scientific and regulatory requirements into clear documentation, defensible decisions, and coordinated global workflows.
Profile
Where regulatory rigor meets practical execution.
Regulatory affairs and technical documentation professional experienced across product lifecycles—from biosimilar analytical development to global medical-device compliance.
My work brings structure to complexity: assessing change impact, authoring submission-ready documents, translating requirements into usable workflows, and keeping cross-functional teams aligned.
I have supported Class II and III medical devices, electromechanical systems, software-driven products, diagnostics, and biopharmaceutical R&D across the United States, Europe, and international markets.
Core expertise
Documentation built for decisions, review, and action.
Technical Documentation
Annual reports, 510(k) support, EU MDR files, GSPR, CEP, PMS plans, PSUR, labels and IFUs.
Quality & Compliance
SOPs, SAPs, CAPAs, GMP records, revision control, audits, 21 CFR Part 11, IQ/OQ/PQ.
Workflow Translation
Templates, trackers, structured reviews, requirements synthesis, training, cross-functional coordination.
Selected experience
A career connecting science, quality, and regulation.
2025–2026Pleasanton, California
Regulatory Affairs Specialist
Abbott
Led change-order assessments and FDA annual-report coordination for electromechanical and software-driven Class II, Class III, and HDE products across a $50M+ global portfolio. Coordinated registration and licensing workflows across 40+ markets.
2024–2025Sunnyvale, California
Regulatory Consultant
Antrix Inc.
Built a regulatory-intelligence database across eight diagnostic categories and synthesized 40+ FDA, EU, and CLSI requirements into organized, usable guidance. Supported submission quality, formatting, and revision control.
2020–2021Pune, India
Senior Engineer — Quality & Regulatory Affairs
Tata Elxsi · Client: Zimmer Biomet
Led EU MDR technical documentation for Class IIa, IIb, and III devices, including SaMD imaging software. Performed MDD-to-MDR gap analyses and authored GSPR documents, clinical and post-market plans, and PSURs.
2015–2020Mumbai & Ahmedabad
Technical Documentation & Biopharma R&D
USV · INTAS Biopharma · Zydus Cadila
Authored controlled laboratory and GMP documentation while leading analytical and method-development work for biosimilars. Supported laboratory systems, validation records, audits, and documentation aligned with 21 CFR Part 11.
Credentials
Deep technical foundations. Current regulatory perspective.
RAC-Devices
Regulatory Affairs Professionals Society
RCC-MDR
Regulatory Affairs Professionals Society
Regulatory Affairs Certificate
University of California, Santa Cruz Silicon Valley
Biotechnology Engineering
Vellore Institute of Technology · GPA 8.51/10
Leadership beyond the document.
- Designed and led a seven-session global regulatory study group for 15+ active participants, coordinating with 8+ subject-matter experts.
- Panel speaker at the RAPS San Francisco Chapter event at UCSF, sharing guidance on entering medical-device regulatory affairs.
- Recognized by RAPS in 2026 for certification leadership, career development, and professional community contribution.
Let’s connect
Complex requirements deserve clear direction.
Open to regulatory affairs, technical documentation, advisory, and domain-expert product opportunities.