Zakir H.

Freelance Regulatory Documentation Specialist

Independent Consultant

May 2024 - Feb 2025 • 9 mos

Delivered freelance regulatory documentation services for startups and SMEs. Developed technical documentation, risk management reports, and clinical documentation in line with EU MDR and ISO standards. Focused on clear, structured, and compliant regulatory deliverables.

Regulatory Affairs Specialist

Medical Device Regulatory Consultancy

Mar 2023 - Feb 2024 • 11 mos

Provided regulatory consulting and documentation support for medical device manufacturers. Assisted in EU MDR transition projects, documentation remediation, and alignment with harmonised standards. Collaborated with cross-functional teams to ensure audit-ready submissions.

Regulatory Affairs Specialist

Pharma Consultancy

Jan 2020 - Apr 2022 • 2 yrs 3 mos

Worked on EU MDR (2017/745)–compliant technical documentation for Class I–III medical devices. Prepared and reviewed Technical Files, Design Dossiers, CERs, Risk Management files (ISO 14971), PMS/PMCF plans, IFUs, and labeling. Supported regulatory gap analyses and conformity assessment readiness for EU market access.