Andreas S.
Interim Head of Risk Management and Usability
Experience
Mar 2023 - Oct 2024
1 year 8 monthsMunich, Germany
Interim Head of Risk Management and Usability
Technolas Perfect Vision GmbH
- Creation and maintenance of risk management files
- Conducting usability studies
- Process validation
- Supporting quality management, e.g., maintaining processes for risk management, usability, design control, and CAPA management
May 2022 - Oct 2022
6 monthsGarching, Germany
Project Manager for Process Validation
ITM Medical Isotopes GmbH
- Coordination of the process validation for a new manufacturing of radioactive drugs
- Preparing validation documentation for regulatory approval
Jun 2021 - Apr 2022
11 monthsTuttlingen, Germany
Facilitator for Risk Management according to ISO 14971:2019
Karl Storz SE & Co. KG
- Risk management for Class III medical devices
- Facilitating risk analyses
- Revising risk management processes according to ISO 14971:2019
- General support in risk management
Sep 2020 - Feb 2021
6 monthsMannheim, Germany
Support in creating and implementing technical documentation and establishing production
Vibrosonic GmbH, Mannheim
- Regulatory approval for clinical trials
- Creation of a DHF
- Risk management in coordination with QM, RA, CA, labeling, R&D, RM, purchasing
- Preparation of technical documentation for national and international approval
- Formative and summative usability assessment
- Validation of manufacturing processes
Jun 2019 - Apr 2020
11 monthsMaisach, Germany
Support for medical device approval
HMT Medizintechnik
- Regulatory affairs manager
- Improving the current quality management system
- Gap analysis of the QM manual
- Gap analysis for product and process validations
- Establishing a risk management system according to ISO 14971
- Technical documentation according to Annex II of the MDR
- Support and coordination in the change of notified body
- Setting up supplier management according to MDR
- Creating usability files according to IEC 62366
Feb 2019 - May 2019
4 monthsBerlin, Germany
Support for medical device approval / Head of Technical Documentation
aap Implantate
- Creation of a risk management file
- Technical documentation for osteosynthesis instruments
- Maintaining open CAPA projects
Apr 2017 - Dec 2018
1 year 9 monthsMunich, Germany
Project Manager for Technical Documentation
Baxter Europe
- Restructuring design control
- Project management for creating technical documentation
- Preparing clinical evaluations according to MEDDEV 2.7.1 revision 4
- Training external staff
- Developing a strategy for the transfer from MDD to MDR
Jun 2016 - Jan 2017
8 monthsWeßling, Germany
Development Project Manager
Dornier MedTec
- Leading a development project
- Organizing product approval
- Preparing technical documentation for international approvals (MDR, 510(k), etc.)
- Gap analysis and improvement/streamlining of existing processes (design control, risk management, post-market surveillance, technical documentation)
- Gap analysis and correction of technical documentation
Apr 2016 - Mar 2017
1 yearMunich, Germany
Risk Manager
PARI Pharma GmbH
- Gap analysis of technical documentation for conformity assessment
- Risk management review
May 2015 - Dec 2015
8 monthsMunich, Germany
Regulatory Affairs Specialist
Baxter Europe, München
- Project management for merging the quality management systems of two companies
- Process mapping for design control, risk management, and CE marking
- Aligning processes between quality management systems of different organizations/manufacturers
- Implementing life-cycle management for conformity assessment under MDD
- Introducing technical documentation for international approval under MDR (2017/745) in the EU and 510(k) for the USA (21 CFR 820)
- Staff training
- Preparing STEDs according to GHTF guidelines
Jan 2015 - May 2015
5 monthsTuttlingen, Germany
CAPA Specialist
Stryker Berchtold
- Reviewing and facilitating CAPA projects
- Equipment qualification
- Process validation (IQ/OQ/PQ)
Apr 2014 - Oct 2014
7 monthsTuttlingen, Germany
Interim Quality Manager
REDA Instrumente
- Support for re-certification audit
- Reviewing the complete quality management system
- Creating technical documentation
- Introducing post-market surveillance for PLM without involving OEM
- International registration (USA, Canada, Brazil, Colombia, Peru, China)
Nov 2013 - Mar 2014
5 monthsRastatt, Germany
Interim Quality Management Representative
Maquet Cardiopulmonary
- Quality management support
- Reviewing the QM system for FDA compliance and DIN EN ISO 13485
- Leading and facilitating CAPA projects
- Conducting internal audits
- Training in quality management
- Managing process validations
Aug 2013 - Nov 2013
4 monthsTuttlingen, Germany
CAPA Management Expert
Johnson und Johnson / Synthes
- Reviewing existing CAPA projects according to FDA 21 CFR 820.100
- Preparing review reports for FDA inspections
- Supporting ongoing CAPA projects in local branches
May 2013 - Aug 2013
4 monthsAarau, Switzerland
Post-Market Surveillance Specialist
Smith & Nephew Orthopaedics AG
- Implementing the post-market surveillance process (PMS)
- Defining and creating reports in PMS
- Preparing IQ/OQ/PQ plans for production site relocation
Sep 2012 - Apr 2013
8 monthsTuttlingen, Germany
Quality Manager and Regulatory Affairs
Sopro-Comeg GmbH
- Implementing, operating, and maintaining a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
- Conducting internal and external audits
- Coordinating and executing CAPA actions
- Establishing and facilitating a risk management system according to ISO 14971
- Product approval according to legal and normative requirements
- Supporting development projects in documentation according to legal and normative requirements
Jan 2010 - Aug 2012
2 years 8 monthsTuttlingen, Germany
Regulatory Affairs Manager
KLS Martin Group
- Creating and updating DHFs according to legal and regulatory requirements
- Implementing legal and normative requirements throughout the product lifecycle
- Supporting coordination and planning of regulatory parts of clinical evaluations, PMCF, and studies
- Preparing dossiers for FDA 510(k) clearances
- Establishing a risk management system according to ISO 14971
- Improving requirements in existing processes
- Building a regulatory affairs management for the entire KLS Martin Group
Jan 2009 - Jun 2009
6 monthsStarnberg, Germany
Quality Manager
StarMedTec GmbH
- Coordinating product approval for the EU, USA, and Asia
- Implementing, operating, and maintaining a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
- Conducting internal and external audits
- Coordinating and executing CAPA actions
- Facilitating alignment of cross-departmental quality processes
- Product approval according to legal and normative requirements
- Supporting development projects
Apr 2008 - Dec 2008
9 monthsMunich, Germany
Quality Manager
Pulsion Medical Systems AG, München
- Implementing, operating, and maintaining a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
- Monitoring the application of quality tools and related tests
- Representing the company with customers and authorities
- Managing complaint handling
- Coordinating and executing CAPA actions
- Leading and coordinating the quality assurance department
- Process validation and qualification for production (IQ/OQ/PQ)
- Introducing new in-process controls in manufacturing
- Conducting internal system and external supplier audits
Mar 2001 - Mar 2008
7 years 1 monthMunich, Germany
Headquarter Complaint Manager
Agfa Gevaert AG
- Facilitating between internal departments and external interfaces
- Introducing global post-market surveillance processes (complaints, CAPA, etc.)
- Developing statistics and trend reports on product quality
- Specifying and implementing a complaint database
- Monitoring complaints recorded in the database and reporting to cross-functional teams and management
- Leading projects to improve product monitoring
- Training on the CAPA process and the complaint system
- Improving QM processes following Six Sigma
- Introducing computerized software validation (CSV)
Sep 1998 - Jan 2001
2 years 5 monthsMunich, Germany
Product Specialist
Agfa Gevaert AG
- 2nd line support for Agfa branches, customers, and dealers
- Field deployments for installations and service calls at customers or dealers
- Conducting system and equipment courses
- Assisting with specifications, validation, and launch of new products
Sep 1993 - Aug 1998
5 yearsMunich, Germany
Product Specialist
TÜV Product Service GmbH
- Coordinator for 510(k) approvals for FDA
- Central coordinator for medical device approvals in Japan
- Auditor and lead auditor for QMS approvals according to ISO 9000 / EN 46000, MDD, and AIMD in Europe, East Asia, and the USA
- Expert for regulatory approval of medical devices
- Member of the CE certification committee
Languages
German
NativeEnglish
AdvancedEducation
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Diploma · Medical Engineering · Ulm, Germany
Certifications & licenses
Cybersecurity for Medical Devices and IEC 81001-5-1
Artificial Intelligence (AI) in Medical Engineering
Medical Device Forum, focus on Cybersecurity, AI Act, Data Act
Risk Management under ISO 9001:2015
Advanced Product Quality Planning - APQP
Process Validation in Medical Devices
Computerized Systems Validation (CSV)
Developing Medical Software in Compliance with Regulations
Medical Device Single Audit Program (MDSAP)
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