Regulatory Strategy
FDA annual reporting, impact assessments, lifecycle changes, global registrations, and 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—while building learning communities and practical resources for MedTech professionals.
Profile
Where regulatory rigor meets practical execution.
Regulatory Affairs professional with 7+ years of combined experience across medical devices, IVDs, SaMD, biologics R&D, quality, and technical documentation.
My work brings structure to complexity: assessing regulatory impact, authoring submission-ready documents, coordinating global registrations, translating requirements into usable workflows, and keeping cross-functional teams aligned.
Alongside regulatory work, I bring experience in entrepreneurship, product research, organic marketing, customer engagement, and professional community building. I am open to international relocation for suitable opportunities.
Core expertise
Documentation built for decisions, review, and action.
Technical Documentation
EU MDR files, GSPR, CEP, PMS plans, PSUR, Letters to File, notified-body notifications, labels, and IFUs.
Quality & Compliance
ISO 13485, ISO 14971, QMSR, SOPs, CAPAs, GMP records, audits, 21 CFR Part 11, and IQ/OQ/PQ.
Product & Growth
Product research, supplier coordination, customer engagement, sales, Canva content, and organic LinkedIn and Instagram marketing.
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. Supported licensing and product registrations across 20+ markets, authored lifecycle documentation, supported audit readiness, and facilitated peer knowledge-sharing on the RAC Devices examination format.
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.
2021–2024India & United States
Entrepreneurial Projects
Independent
Created from scratch, developed, and operated two profitable small businesses focused on children's products with minimal startup investment, managing product research, supplier coordination, marketing, customer sales, and daily operations.
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 Extension
Business Analysis Certification
International Institute of Business Analysis, Canada
Biotechnology Engineering
Vellore Institute of Technology · GPA 8.51/10
Biotechnology Engineering
Gujarat Technological University · GPA 7.73/10
Entrepreneurial & community leadership.
- Founder — MedTech Hub: Developing a cross-functional platform for curated articles, events, learning resources, professional discussions, Q&A, and mentor connections.
- Founder & Learning Architect — RAC Devices Learning Cohorts: Designed and led a seven-session global learning cohort for 15+ active participants, coordinated 8+ subject-matter experts, and secured six paid Cohort 2 enrollments through organic outreach and Canva-created marketing assets. Visit Cohort 2 ↗
- Global Communications Advisory Committee Member — RAPS: Supports social-media, digital-content, and community-engagement initiatives.
- Featured by RAPS on LinkedIn: Recognized in February 2026 for regulatory career progression, certification achievement, and community contribution.
- Panel Speaker — RAPS San Francisco Chapter at UCSF: Shared career insights on transitioning into the medical-device industry.
Let’s connect
Complex requirements deserve clear direction.
Open to regulatory affairs, technical documentation, advisory, product-focused opportunities, and international relocation for suitable roles.