Medical Device Assistant

SUKANYA SAHA

Boston, MA, ***** 857-***-**** ****.**********@*****.*** linkedin.com/in/sukanya-saha Skills

• Strategize regulatory submissions and documentation of: 510K, PMA,IDE, IND, NDA, ANDA, BLA, CMC Analysis, Orphan drug & Paediatric Drug Development for US-FDA, EU-EMA, Japan-PMDA, Canada, Brazil, Australia & China

• Proficient in Medical Device Regulations, Design & Change control management, MDR, labelling, compliance with Global QMS, CAPA, Verification & Validation, Post-marketing Surveillance

• Expertise in interpretation and application of FDA 21 CFR (720,800,812,820) & ICH guidelines, various technical files like DMF, DHF & CTD, Risk Assessment & Adverse Event Reporting

• Tools: MS Outlook, MS PowerPoint, MS Word, MS Excel, SAS programming, Adobe Acrobat, Salesforce, ONBASE

• Certifications: NIH Web-based training course for “Protecting Human Research Participants” Education

MCPHS University Boston, MA May 2018

Master’s in Regulatory Affairs and Health Policy (GPA: 3.73/4.00) Coursework: Global RA, Advanced RA, Development of Medical Devices, FDA Regulations, Law and Health Policy of Drugs

& Devices, Protection of Human Research Subjects, Capstone Project, Biostatistics, Health Epidemiology NMIMS University Mumbai, India May 2016

Bachelor’s in Pharmacy

Coursework: Pharmaceutics, Pharmaceutical Management, Pharmaceutical Engineering, Clinical, Biostatistics and Computer Applications, Pharmacology, Medicinal Chemistry, Pharmacovigilance, Regulatory Affairs and IP Laws Lab work: Chromatography, electrophoresis, compression & testing techniques, ELISA, HPLC, purity assays Experience

Celogen Pharma Pvt. Ltd, Navi Mumbai April 2015- July 2015 Intern, Research and Development Center

1. Optimized in-house blend of Tadalafil, Naproxen and Metformin, verified & tested the purity and quality of the finished batches 2. Preparation of dossiers & technical documents of the drugs, maintenance of batch manufacturing record

• Identified loopholes causing problems & offered well-developed solutions

• Handled multiple projects & managed to report cross-functional teams with the required documents MCPHS University September 2016- April 2018

Admissions Assistant -Evaluated & compiled reports on course credit, conducted campaigns for Admissions Department Teaching Assistant – Supervised exams for Pharmaceutical Department

• Adhered to all institutional standards for organizational, interpersonal & professional behaviour ACADEMIC PROJECTS (MCPHS University)

1. Conceptualized and presented in the Nestle Business Hackathon-SHIELD, New York’17 March 2017

• Adaptive team worker in highly dynamic situations with flexibility to resolve conflicts efficiently

• Communicated excellently to disseminate detailed concepts into understandable ideas 2. Created an application prototype for Bulimic patients and drafted informed consent forms April 2017

• Appreciated for highly detailed & innovative project 3. Capstone (Paper and poster)- “Insight of the reasons behind the exorbitant prescription drug pricing in the US” October 2017

• Scrutinized large volumes of data & identified trends to understand broad range of issues

• Managed unpredictable challenges & time constraints calmly when under pressure by prioritization 4. Analyzed the updated EudraVigilance by EMA and case studies like Andrea Sloan’s, Trojan trial October 2017 5. Strategized and devised a regulatory pathway for US-FDA approval of a Class III device & Orphan Drug April 2018

• Integrated criticism with analytical mindset for improvisations, passionate about strategizing regulatory submissions

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