Andreas Seidl

Interim Head of Risk Management and Usability

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
Languages
German
Native
English
Advanced
Education
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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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