Joseph Nguyen Email & Phone Number

Copenhagen, Dk

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:• 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 regulatory representative in cross-functional and international projects with focus on Design Control and Risk Management. • Product responsible for medical devices (Class I and II). • Country responsible for regulatory activities in Asia Emerging Market including monitoring of regulatory intelligence • Coordinate and compile high quality registration files worldwide and responsible for preparing files to the FDA and for documenting product changes by writing Letter to 510(k) files. • Interact with healthcare authorities as needed to clarify requirements, answering questions, submission of documentation to tenders and negotiate regulatory requirements. • Conduct review and approval of labeling and promotion materials including online promotions and campaigns.• Writing Investigators Brochure for clinical study submissions Show less

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