Andreas S. - Interim Head of Risk Management and Usability

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Grafing bei München, Germany

Experience

Mar 2023 - Oct 2024

1 year 8 months

Munich, 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 months

Garching, 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 months

Tuttlingen, 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 months

Mannheim, 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 months

Maisach, 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 months

Berlin, 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 months

Munich, 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 months

Weßling, 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 year

Munich, Germany

Risk Manager

PARI Pharma GmbH

Gap analysis of technical documentation for conformity assessment
Risk management review

May 2015 - Dec 2015

8 months

Munich, 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 months

Tuttlingen, Germany

CAPA Specialist

Stryker Berchtold

Reviewing and facilitating CAPA projects
Equipment qualification
Process validation (IQ/OQ/PQ)

Apr 2014 - Oct 2014

7 months

Tuttlingen, 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 months

Rastatt, 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 months

Tuttlingen, 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 months

Aarau, 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 months

Tuttlingen, 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 months

Tuttlingen, 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 months

Starnberg, 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 months

Munich, 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 month

Munich, 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 months

Munich, 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 years

Munich, 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