2022 - today: Support the transition planning of medical device product portfolio

Role: Quality Assurance and Regulatory Affairs Manager, Quality Assurance and Regulatory Affairs Consultant

Customer: Baxter Global

Tasks:

• Support the transition planning of medical device product portfolio from the MDD to the Regulation (EU) 2017/745
• Support remediation of the EU MDR compliance identified during gap assessments
• Provide guidance to multifunctional teams to ensure the
• EU MDR certification requirements are met for the medical device product portfolio (medical devices class II b and III)
• Review and approve products documentation for compliance with the MDD and the EU MDR requirements

2021 - 2022: Compilation of a Technical File for in vitro medical device class D

Role: Regulatory Affairs Consultant

Customer: UK Health Security Agency

Tasks:

• Compilation of a Technical File for in vitro medical device class D
• Development of regulatory procedures in compliance with UK MDR 2002, IVDD
• Supporting the compilation of design and development documentation in compliance with the UK
• MDR 2002, IVDD requirements, EU MDR
• Supporting the remediation activities for the IVDR compliance

2020- 2021: Responsibility for a Notified Body audits against

Role: Quality Assurance Manager

Customer: Image Analysis LTD

Tasks:

• Responsibility for a Notified Body audits against: (ISO 13485, MDD 93/42/EEC, FDA 21 CFR part 820)
• Responsibility for remediation activities for the EU MDR compliance
• Providing regulatory support for new product development
• Compilation of a Technical File for medical device software class II a
• Development of QMS system against ISO 13485:2016
• Management of CAPA, change control and trainings