Joseph Nguyen Email & Phone Number

Copenhagen, DK

Søborg

Denmark

- Implementation Lead of a Product Lifecycle Management (PLM) system; MinervaPLM powered by ARAS - Application owner of JAMA used for Requirement management, risk management and test management

Denmark

Implementation Lead of the European Medical Device Regulation (MDR) 2017/745

Copenhagen Area, Denmark

• Project Lead on implementation of FDA's UDI requirements in 3Shape organization
• Regulatory Partner in Product Development projects
• Lifecycle Management and obtaining CE-marking

Coloplast HQ, Humlebæk

• Experiences:
• Range care and obtaining CE-mark: Review of technical documentation incl. Clinical evaluation review, Biological evaluation review and sterilization (EO & E-beam).
• Life Cycle Management activities; Maintaining design history file documentation on existing products in connection with product modifications, transfers, re-branding, discontinuation etc.
• Establish regulatory strategies for Medical Devices and execute it in cross-functional projects. Act as… Show more Experiences:
• Establish regulatory strategies for Medical Devices and execute it in cross-functional projects. Act as regulatory representative in cross-functional and international projects with focus on Design Control and Risk.
• Product responsible for medical devices (Class I and II).

Søborg

Master thesis in Public Health. The topic was Ethnic variations in the prevalence of diabetes by BMI group – A NHANES study.An abstract of my thesis was sent to the ADA, and was approved to be presented as a poster at the ADA Conference in June 2013.

Master, Public Health

Graduate Diploma In Organisation And Management (Hdo)

Graduate Diploma (Hd1)

Bachelor, Public Health

Semester Course, Health Economics