Resumes
Resumes
Director Of Regulatory Affairs
View pageLocation:
Northborough, MA
Industry:
Medical Devices
Work:
Sophia Genetics
Director of Regulatory Affairs
Cardiofocus Mar 2015 - Apr 2019
Senior Regulatory Affairs
Syneron Candela Feb 2014 - Mar 2015
Global Regulatory Affairs
Medical Devices Jan 2012 - Feb 2014
Regulatory Affairs and Quality Assurance, Independent Consultant
Umass Medical School Mar 2003 - Jun 2013
Instructor, Faculty, Department of Cancer Biology and Surgical Oncology
Director of Regulatory Affairs
Cardiofocus Mar 2015 - Apr 2019
Senior Regulatory Affairs
Syneron Candela Feb 2014 - Mar 2015
Global Regulatory Affairs
Medical Devices Jan 2012 - Feb 2014
Regulatory Affairs and Quality Assurance, Independent Consultant
Umass Medical School Mar 2003 - Jun 2013
Instructor, Faculty, Department of Cancer Biology and Surgical Oncology
Education:
Indian Veterinary Research Institute, Izatnagar 1991 - 1993
Master of Science, Masters, Biotechnology Rohilkhand University
Bachelors
Master of Science, Masters, Biotechnology Rohilkhand University
Bachelors
Skills:
Medical Devices
Clinical Research
Writing
Regulatory Affairs
Quality Assurance
Quality System
Oncology
Drug Development
Pharmaceutical Industry
Fda
Iso 13485
Mdd
Gmp
Capa
Sop
21 Cfr Part 11
Root Cause Analysis
510K
Technical Writing
Literature Reviews
Document Review
Pre Clinical Studies
Data Analysis
Data Management
Process Management
Canadian Standards
Regulatory Submissions
Clinical Research
Writing
Regulatory Affairs
Quality Assurance
Quality System
Oncology
Drug Development
Pharmaceutical Industry
Fda
Iso 13485
Mdd
Gmp
Capa
Sop
21 Cfr Part 11
Root Cause Analysis
510K
Technical Writing
Literature Reviews
Document Review
Pre Clinical Studies
Data Analysis
Data Management
Process Management
Canadian Standards
Regulatory Submissions
Interests:
Science and Technology
Education
Arts and Culture
Health
Education
Arts and Culture
Health
Languages:
English
Hindi
Hindi
Certifications:
Regulatory Affairs Certificate In Medical Device and Pharmaceuticals
Iso 13485: 2003 Auditor Training For Medical Devices
Citi Collaborative Institutional Training Initiative on Clinical Research As Biomedical Research Investigator Conducted By the University of Miami and the Fred Hutchinson Cancer Research Center
Nih Clinical Research Training Course Conducted By the Nih Office of Clinical Research Training and Medical Education
Iso 13485: 2003 Auditor Training For Medical Devices
Citi Collaborative Institutional Training Initiative on Clinical Research As Biomedical Research Investigator Conducted By the University of Miami and the Fred Hutchinson Cancer Research Center
Nih Clinical Research Training Course Conducted By the Nih Office of Clinical Research Training and Medical Education
Seema Paliwal
View page
Seema Paliwal Northborough, MA
View pageWork:
GE Healthcare
Consultant
Neurotherm
Consultant
Ergonomic Products
Consultant
Consultant
Neurotherm
Consultant
Ergonomic Products
Consultant
Education:
RAPS
2010 to 2011
Regulatory Affairs Certificate Program (RAPS) in Medical Devices and Pharmaceuticals (Dual)
Online training
2011
Auditor Training for Medical Devices in ISO 13485: 2003
University of Miami and the Fred Hutchinson Cancer Research Center
2011
CITI Collaborative Institutional Training Initiative on Clinical Research as Biomedical Research Investigator in Clinical research
NIH Office of Clinical Research Training and Medical Education
2011
NIH Clinical Research Training in Clinical Research
Delhi University
New Delhi, Delhi
1999
PhD in Molecular Biology
2010 to 2011
Regulatory Affairs Certificate Program (RAPS) in Medical Devices and Pharmaceuticals (Dual)
Online training
2011
Auditor Training for Medical Devices in ISO 13485: 2003
University of Miami and the Fred Hutchinson Cancer Research Center
2011
CITI Collaborative Institutional Training Initiative on Clinical Research as Biomedical Research Investigator in Clinical research
NIH Office of Clinical Research Training and Medical Education
2011
NIH Clinical Research Training in Clinical Research
Delhi University
New Delhi, Delhi
1999
PhD in Molecular Biology