Experience

1MED SA

• Switzerland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Apr 2021 - Present

• Senior Regulatory Specialist

  • Feb 2020 - Apr 2021



Corin Group

• United Kingdom
• Medical Equipment Manufacturing
• 400 - 500 Employee

• Senior Regulatory Affairs Associate

  • Jan 2019 - Oct 2019

  - Generation, submission and maintenance of Design Dossiers and Technical Files for registration of medical devices (MDD Class I, IIa, IIb and III) in the EU - Generation and submission of 510(k) submissions for the registration of products in the USA - Evaluation of literature identified from relevant databases (e.g. PubMed) and compilation of literature reviews for orthopaedic devices - Creation Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 - Support other international submissions - Support, supervise and participate in the development and update of package inserts for compliance with appropriate regulations - Provide guidance to a number of departments including but not limited to Manufacturing, Quality Assurance, Operations, Sales and Marketing, Product Management, and Clinical on Regulatory issues- Provide regulatory input for new product development projects - Complete 510(k) minor modifications - Complaints and Vigilance system maintenance - Investigation of product complaints - Adverse event reporting to appropriate competent authorities - Provide regulatory input to CAPA activities - Auditing to ISO 13485 and CFR 21 requirements- Risk Management ISO 14971

• Regulatory Affairs Associate

  • Aug 2015 - Jan 2019

  - Generation, submission and maintenance of Design Dossiers and Technical Files for registration of medical devices (MDD Class I, IIa, IIb and III) in the EU - Generation and submission of 510(k) submissions for the registration of products in the USA - Evaluation of literature identified from relevant databases (e.g. PubMed) and compilation of literature reviews for orthopaedic devices - Creation Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 - Support other international submissions - Support, supervise and participate in the development and update of package inserts for compliance with appropriate regulations - Provide guidance to a number of departments including but not limited to Manufacturing, Quality Assurance, Operations, Sales and Marketing, Product Management, and Clinical on Regulatory issues- Provide regulatory input for new product development projects - Complete 510(k) minor modifications - Complaints and Vigilance system maintenance - Investigation of product complaints - Adverse event reporting to appropriate competent authorities - Provide regulatory input to CAPA activities - Auditing to ISO 13485 and CFR 21 requirements- Risk Management ISO 14971

• Regulatory Affairs Technician

  • Jun 2012 - Aug 2015

  - Responsible for technical and regulatory support in the areas of sterilisation, cleaning and packaging of sterile devices - Sterilisation validation in line with ISO 11137 and 11135 - Routine environmental monitoring of the cleanroom - Process validation - Packaging validation - Writing and maintaining QMS documentation with regards to Sterilisation and Environmental Monitoring - Complaints and Vigilance system maintenance - Investigation of product complaints - Provide regulatory input to CAPA activities - Adverse event reporting to appropriate competent authorities - Auditing to ISO 13485 and CFR 21 requirements



Q Park Medical

• Quality Assistant

  • Nov 2011 - Jun 2012

  - Assistant to Regulatory and Technical Director - Maintenance of Technical Files for class I and IIa devices - Development of prototypes - Change control - Internal auditing - Assistant to Regulatory and Technical Director - Maintenance of Technical Files for class I and IIa devices - Development of prototypes - Change control - Internal auditing