ASHWINI SACHIN GUNDE
Regulatory Affairs Specialist-Medical Devices-IVD
Pune
Summary
Dynamic and result-oriented professional with over 12 years of experience in preparing and submitting regulatory documentations. Skilled in IFU preparation, labeling for in-vitro diagnostics medical devices, diagnostics kits development, clinical trial laboratory management, and central laboratory operations. Proficient in clinical trials management, including planning, co-ordination with clinical trial sites, discrepancy management, and logistic part. Familiar with MDR 2017/745 IVDR 2017/746 ISO 13485. Demonstrated expertise in regulatory compliance, documentation, and submissions. A thorough team contributor with strong organizational capabilities, adept at prioritizing tasks and meeting deadlines.
Overview
17
17
years of professional experience
4009
4009
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
Regulatory Affairs Specialist
BreathX Technology
05.2021 - 01.2023
- Regulatory medical writing - documents preparation and review – Technical files, IFUs (Instruction for Use), artwork (Labels, symbols, QRI, pack inserts) etc
- Prepared and submitted regulatory file applications and supporting documentation.
- As per the regional requirement according to guidelines and available standardize templates (FDA, SFDA, EU, Health Canada etc.), provide content for company website, Clinical trial data analysis, submission process to concern regulatory authority
- Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
- Knowledge of Classification of device as per IVDR 2017- 746 & MDR 2017 - 745
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Worked on Emergency use Authorization submission process for EUA FDA, Health Canada and EU
- Documents preparation for post submission query response
- Preparation of documents and filling of forms required to obtained CE certification for the product
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
- Perform and/or verify regulatory searches for updated regulations and guidance documents impacting submissions and other projects
- Provide Regulatory support for post market surveillance activities and marketing activities which includes monitoring of safety of device, adverse events reporting, reporting of any product related issues by patients, health care professional or by end user
- Collection of device related data from market and continuous monitoring of device for safety
- CAPA document preparation
- Support to Quality team to develop and review documents related to QMS - ISO 13485, Preparation of SOPs
Executive - Research and Development
Transasia Biomedical Pvt Ltd.
02.2010 - 03.2018
- Collaboration and liaison with various functions to plan and schedule quality control check for automation as well as diagnostics kits
- Evaluation of blood specimens in the laboratory for detection of various disease such as Cancer, infectious (HIV, HCV, HBV), Fertility etc
- Standardization of Assays Protocols (ELISA Based and Reagents - finding match pairs for capture and detection
- Competitor analysis- Testing of competitor ELISA kits
- QC testing of diagnostics kits and Stability testing for the kit
- Oversee production batch records final approval and batch release
- Preparation and keeping records of ISO 13485 document, dossier preparation for technical product files
- Overseeing operations of in-house ELISA analyzers, Coagulation analyzer
- Overseeing of instruments (Calibration/Probe cleaning)
- Designing of assay protocol on instruments
- Reagent stability testing on instruments
Scientific Officer and Study coordinator
Dhirubai Ambani Life Sciences Centre
11.2005 - 01.2010
- Worked as a "Laboratory Technician" overseeing the complete Central Laboratory Operations including processing of study samples ,reporting along with Clinical Study activities.
- Complied with research protocols by providing ongoing quality control audits.
Education
Diploma - Medical Lab Technology
Bharati Vidyapeeth
Mumbai, India05-2005
Bachelor of Science - Chemistry
K.J. Somaiya College of Science And Commerce
Mumbai, India05-2003
Skills
Regulatory policies
Training
- Operators training on Dade Behring Dimension Xpand Plus, 11/01/05
- Operators training on Labindia Pico+ Ph meter, 12/01/05
- Operators training on interfacing software for the instruments Dade Behring and XT 1800i (Opel Software), 02/01/06
- Awareness training programme on Good Laboratory Practice, 03/01/06
- Post installation training on Dade Behring’s BEP 2000 Advance ELISA Processor, 02/01/07
- Quality Awareness seminar (By BIO-RAD), 09/01/08
- EQAS interpretation and QC data management Meet (by BIO-RAD), 03/01/08
- Online courses - ISO 13485:2016, IVDR 2017-746, EU-MDR-2017/745 Regulatory Affairs, Ongoing
- Core team responsible for obtaining the CAP (College of American Pathologists) Accreditations and certifications., Ongoing
Personal Information
- Date of Birth: 05/10/82
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Accomplishments
- Online courses - ISO 13485:2016, IVDR 2017-746, EU-MDR-2017/745 Regulatory Affairs
- Core team member for obtaining the CAP (College of American Pathologists) Accreditations and certifications.
Certification
ISO 13485:2016, IVDR 2017-746 Accreditations and certifications.
Timeline
ISO 13485:2016, IVDR 2017-746 Accreditations and certifications.
03-2022
Regulatory Affairs Specialist
BreathX Technology
05.2021 - 01.2023
Executive - Research and Development
Transasia Biomedical Pvt Ltd.
02.2010 - 03.2018
Scientific Officer and Study coordinator
Dhirubai Ambani Life Sciences Centre
11.2005 - 01.2010
Diploma - Medical Lab Technology
Bharati Vidyapeeth
Bachelor of Science - Chemistry
K.J. Somaiya College of Science And Commerce
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