Bedwuine Senatus

Bedwuine Senatus has a strong background in quality and regulatory affairs within the medical device industry. Starting in 2014, they worked at Integra LifeSciences as a Manufacturing Specialist/Engineer until 2016. In 2016, they transitioned to Medical Indicators, where they held multiple roles including Quality System Specialist, Quality and Regulatory Affairs Manager, and currently serve as the Quality and Regulatory Director. At Medical Indicators, Bedwuine has managed the transition of EU MDR and UK MDR regulations, developed regulatory SOPs for compliance, prepared NAFTA for foreign customers, managed a team, reviewed labeling and marketing materials for regulatory compliance, and communicated with regulatory authorities to resolve issues. They also maintained quality management systems documentation, led audits, and advised management on significant findings and product issues.

Bedwuine Senatus holds a Master's degree in Biomedical/Medical Engineering from the New Jersey Institute of Technology, which was obtained from 2010 to 2013. Prior to that, Senatus earned a Bachelor's degree in Chemistry/Biochemistry from Bloomfield College, completed from 2005 to 2009. Senatus has also obtained several additional certifications, including Lean Six Sigma Yellow Belt (ICYB) from Knoware International Inc in 2020, Certified Clinical Evaluation Report Writer from Oriel STAT A MATRIX in 2019, BSI Certified Internal Auditor (ISO 13485:2016) from BSI in 2018. Senatus is also a member of the Regulatory Affairs Professional Society and has pursued Regulatory Affairs Certification (RAC) from RAPS University.