Aastha Chaudhary Senior Quality and Regulatory professional | MedTech | SaMDs |

Quality and Regulatory Manager (Part-time)

Navier Medical

Jun 2025 - Current (1 year 3 months)

Head Quality and Regulatory (Part-time)

Beamtree

Apr 2023 - Current (3 years 5 months)

Reporting into the CTO, the focus of my job is to handle company's Q&R needs. Act as Quality Management representative. Prepare Regulatory strategies and file for reg submissions. Manage regulatory projects.

Quality & Regulatory Manager

Max Kelsen

Feb 2022 - Apr 2023 (1 year 3 months)

Guest Speaker

Monash University

Aug 2020

Delivered lecture to Masters of Bioengineering students on Medtech Regulatory Affairs requirements worldwide in 2018 and 2020.

Guest Speaker

University of Melbourne

Aug 2018

Delivered lecture on Regulatory Affairs requirements for Medical Devices.

Q&R Manager (Head of Quality)

Hydrix

Jun 2018 - Feb 2022 (3 years 9 months)

Management Representative for the company. Maintain ISO 13485 and 21 CFR Part 820 compliant Quality Management System. Participate in External Audits, conduct Internal Audits. Handle Document Control, Complaints, CAPA. Implement QMS and EDMS for clients. Handle ISO 13485 certification process on behalf of clients. Advise internal and external clients on Regulatory requirements and submissions worldwide. Draft Regulatory Strategies for the clients. Advise Product Development teams on regulatory and quality requirements identified for different products under development. Conduct gap analysis to ensure compliance to ISO 13485, IEC 62304, ISO 9001, and FDA CFR requirements.

Q

Quality and Regulatory Consultant

Qualirooio

Aug 2017 - Current (9 years 1 month)

Guide medical device organizations through strategic transformations by implementing robust QMS frameworks and regulatory strategies for devices including AI/ML SaMDs. Compile and submit 510k submissions, EU CE Mark, UK CA Mark, and registrations across APAC. Advise on new AI/ML guidelines to ensure compliance with international standards. Help companies bring their products to market by providing regulatory advice, and compile submissions per the relevant standards and regulations, including but not limited to ISO 13485, IEC 62304, IEC 62366, ISO 27001, ISO 42001, ISO 14971. Implement Quality Management Systems and act as Quality Management Representative.

Quality Specialist

Hydrix

Jul 2017 - Jun 2018 (1 year)

Implemented ISO 13485:2016 and ISO 9001:2015. CAPA and Complaints Manager. Handled Document Control. Conducted Internal Audits for the company.

Maternity Leave

NA

Jul 2015 - Jul 2017 (2 years 1 month)

Took some time off to spend time with my newborn. Moved to Melbourne.

Quality/Regulatory

Heartflow

Nov 2012 - Jul 2015 (2 years 9 months)

Worked within the Q&R group- Acted as Internal Auditor for the company. Managed Doc Control, CAPAs, NCMRs, Quality Improvement Plans. Member of the DeNovo submission team. Performed literature review and analysis to support FDA/ CE mark submissions.

Audit Specialist

Abbott

Aug 2011 - Nov 2012 (1 year 4 months)

Monitored and reported AQR/FDA Observations. Member of the FDA Warning Letter response team. Responsible for ensuring and tracking audit readiness activity and maintain documentation provided by consultants during audit simulation and strategy sessions. Participated in FDA audit. Acted as primary document controller in audit ready room and ensure all documents and requests are tracked and filed. Revised and updated Quality SOPs.

Quality Engineer

CIRTEC MEDICAL

Jan 2010 - Dec 2011 (2 years)

Compiled and maintained DHF, DHR, DMR for client products. Performed QC checks of parts and final product. Responsible to maintain CAPAs and NCMRs. Conducted Internal Audits. Core team member of cross functional teams including CAPA team, MRB, and Design Review team.

Regulatory Affairs Intern

Progenics Pharmaceuticals Inc

Jun 2009 - Sep 2009 (4 months)

Plan, co-ordinate, and execute Regulatory Projects. Assist in preparation of SOP (development and review). Investigate regulatory history of similar products to assess approval implications. Keep the records in compliance with the Regulations and apply risk-benefit techniques. Process Controls and Validation. Review acceptability of quality, preclinical and clinical documentation and data, statistical methods and analysis, Environmental Control. Monitor and Utilize tracking and Control Systems; and Risk Analysis.

Regulatory Operations Associate

Fresenius Medical Care

Jan 2009 - Dec 2010 (2 years)

Developed standards requirements checklists to be included in 510k submission and device license application in Canada. Acted as document controller for Production. Conducted gap analysis in compliance to ISO 13485.

I

Intern

INCA Informatics

Jan 2008 - May 2008 (5 months)

Aastha Chaudhary

About

Detail

Timeline

Résumé