Experience

regenold GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Managing Director

  • Jul 2021 - Present

  Manging Director at regenold GmbH Manging Director at regenold GmbH



CE plus

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Head of Regulatory Affairs Non-Active Medical Devices

  • Jan 2012 - Jun 2021

  CE conformity assessment procedures for non-active medical devices of all risk classes. Specialised for drug-like medical and combination products incorporating, as an integral part, an ancillary medicinal substance. Establishment of Quality Management Systems according to EN ISO 13485 EN ISO 13485 auditing experience (Including supplier audits for clients e.g. raw material supplier, contract manufacturer and laboratories) Compilation of technical documentation for non active medical devices for all risk classes including maintenance in regard to regular updates of technical documentations in compliance to MDD/93/42/EEC Annex I Essential Requirements Risk Management according to EN ISO 14971 Support for annual audits at customer companies (according EN ISO 13485) Quality Management representative of the Integrated Management System of Medical DeviCE+ GmbH Show less



NEXTEC medical GmbH

• Badenweiler, Baden-Württemberg, Deutschland

• Managing Director

  • May 2018 - Jan 2021

  NEXTEC medical GmbH acts as: - “legal” manufacturer according to Article 10 of MDR 2017/745 for products CE-marked and placed on the EU market -Authorized representative according to Article 11 of MDR 2017/745 for “legal” manufacturers outside EU -contract developer of medical device software including AI applications NEXTEC medical GmbH acts as: - “legal” manufacturer according to Article 10 of MDR 2017/745 for products CE-marked and placed on the EU market -Authorized representative according to Article 11 of MDR 2017/745 for “legal” manufacturers outside EU -contract developer of medical device software including AI applications



regenold GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Apr 2009 - Dec 2011

  Compilation of Module 3 and 2.3 (Quality) for drugs in DCP or MRP procedures as well as for international registrations Strategic support within final registration procedure in regard to authority communication Part of the Integrated Management System Team (IMS) of Dr. Regenold GmbH Compilation of Module 3 and 2.3 (Quality) for drugs in DCP or MRP procedures as well as for international registrations Strategic support within final registration procedure in regard to authority communication Part of the Integrated Management System Team (IMS) of Dr. Regenold GmbH



D

• Düsseldorf und Umgebung, Deutschland

• Regulatory Affairs Manager for IVD´s

  • Jan 2008 - Mar 2009

  - Product Manager for development of heart attack rapid tests (Point-of-Care-Tests) - Quality Management according to EN ISO 13485 - Product Manager for development of heart attack rapid tests (Point-of-Care-Tests) - Quality Management according to EN ISO 13485