About Betina Bandojo:
7+ years experience in the medical device industry
Experience
Regulatory Compliance Engineer
September 2019 to Present
Huntleigh Healthcare Medical
- Lead in the maintenance and update to medical device technical files in accordance with MDR 2017/745
- Support R&D processes, contributing to product compliance including the compiling of objective evidence for technical files
- Support the maintenance and control of design history files
- Review and advise on R&D documentation to ensure compliance with relevant standards/regulations
- Coordinate the update of Clinical Evaluations in accordance with MEDDEV 2.7/1
- Assess product and manufacturing changes for impact on current and
planned approvals - Perform internal audits of the QMS
Education
- Master graduate in Renewable Energy & Resource Management, Distinction University of South Wales, 2018 - 2019
- A Graduate of B.Sc. in Industrial Biochemistry, 2.1 Honours Degree University of Limerick, 2010 - 2014
Professionals from different sectors near Pontarddulais, Pontardulais, City and County of Swansea
Scott massey
Motor vehicle technician IMI level 3
Manufacturing / Mechanical
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