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Shivani Nikam
Associate - Quality Compliance & Regulatory Affairs at Predible Health
Education
• ottovonguericke university magdeburg
• watumall institute of electronic engineering and computer technology worli mumbai india
• s.n.d.t. womens university mumbai maharashtra india
Companies
• apoqlar
• inlinemed gmbh
• nference
• predible health
• adventum
• veol medical technologies p ltd
• biosense
• simtek medico systems pvt. ltd. india
• aplab limited
Experience
4.8 Years
Find anyone’s contact
Experience
Associate - Quality Compliance & Regulatory Affairs
predible health | Bengaluru, Karnataka, India
2020 - 2022
Senior Executive - Regulatory Affairs & Biomedical Engineer
adventum | Bengaluru, Karnataka, India
2020 - 2020
Executive - Regulatory Affairs
veol medical technologies p ltd | Navi Mumbai, Maharashtra, India
2019 - 2020
Intern - Production Engineer
simtek medico systems pvt. ltd. india | Mumbai, Maharashtra, India
2013 - 2014
Skills
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auditing
Biomedical Electronics
Clinical evaluation report
EU MDR
IEC 60601
IEC 62304
Internal Audit
internal audit
Internal Audits
ISO 13485
ISO 14971
Leadership
Medical Devices
Medical electronics
Microsoft Excel
Microsoft Office
quality assurance (QA)
Quality Control
Regulatory Affairs
Regulatory Compliance
Regulatory Documentation
Regulatory Requirements
Regulatory Submissions
Research
Research Scientist
Search
Technical Documentation
Troubleshooting
Contact Details
Email (Verified)
shiXXXXXXXXXXXXXXXXXXXXomMobile Number
+91XXXXXXXXXXEducation
ottovonguericke university magdeburg
Master's Medical Systems Engineering
2022 - 2024
watumall institute of electronic engineering and computer technology worli mumbai india
Bachelor of Engineering
2014 - 2017
s.n.d.t. womens university mumbai maharashtra india
Diploma
2010 - 2014
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