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Frederiksværk
Basant Bajpai

Basant Bajpai

QA/RA & Scientific/Clinical Affairs Manager

Farmaceutisk \/ Bio-tech

Frederiksværk, Halsnæs Kommune
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Om Basant Bajpai:

Biomedical Engineer with Doctorate in Neurosciences (Brain Monitoring). Gathered experience in QA/RA engineering. 

7+ years of international work experience. Confident in working multi-functional, overseas team across various cultures and competencies.

Strengths: Communication, Inspiring Personal values: Genuineness, Striving for continuous improvement. 

Specialties: FDA 510K applications, ISO 13485, Quality Management, Medical Devices, Risk Analysis, DFMEA/PFMEA, EU MDR/IVDR.

Competencies:
Worked in R&D for >4 years (Neuromonitoring), 
-Quality Assurance (Regulatory Requirements, Audits, QMS, New Product development, Product and process lifecycle management, supplier control and management, project, Design Control, Design transfer, Design change, IVDR/ MDR, Risk Management, Process Validations & Verifications, Design V&V)
-People manager of teams with direct reports
- Worked in complex Matrix Organizational setups
- Leading Continuous improvement projects 
- Passionate about people management and leadership

Erfaring

7+ years experience in medical device & software, quality management, quality procedures, design control, change control, CAPA, Risk analysis (FMEA), technical file, FDA 510(k), regulatory standards, instrument Testing. Currently workingas a QA/RA & Scientific/Clinical Affairs Manager in Brainreader A/S, Carlsberg, Denmark

Uddannelse

Have a doctorate (Ph.D.) degree in Biomedical Engineering. 

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