Benjamin Kraus - MDR Transition with PRRC-Function

Q: Where is Benjamin based?

Benjamin is based in Essen, Germany .

Q: What languages does Benjamin speak?

Benjamin speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Benjamin have?

Benjamin has at least 25 years of experience. During this time, Benjamin has worked in at least 11 different roles and for 9 different companies . The average length of individual experience is 2 years and 3 months . Note that Benjamin may not have shared all experience and actually has more experience.

Q: What is Benjamin's latest experience?

Benjamin's most recent position is MDR Transition with PRRC-Function .

Q: What companies has Benjamin worked for in recent years?

In recent years, Benjamin has worked for Sanofi ICF Campus Frankfurt , Heraeus Medevio Global , and B.Braun Medical AG + B.Braun Melsungen AG .

Q: Which industries is Benjamin most experienced in?

Benjamin is most experienced in industries like Healthcare , Pharmaceutical , and Manufacturing . Benjamin also has some experience in Beauty and Cosmetics .

Q: Which business areas is Benjamin most experienced in?

Benjamin is most experienced in business areas like Quality Assurance (QA) , Project Management , and Supply Chain Management . Benjamin also has some experience in Operations , Production/Manufacturing , and Product Development .

Q: Which industries has Benjamin worked in recently?

Benjamin has recently worked in industries like Healthcare and Pharmaceutical .

Q: Which business areas has Benjamin worked in recently?

Benjamin has recently worked in business areas like Quality Assurance (QA) , Project Management , and Supply Chain Management .

Recommended expert

Essen, Germany

Experience

Jun 2024 - Present

1 year 9 months

MDR Transition with PRRC-Function

PRRC according to Article 15 MDR 2017/745
Lead MDR transition for legacy products
Communication with the notified body DQS
Lead technical documentation
Strategy in activities under MDR 2017/745
Topics from the development department
Risk management according to ISO 14971:2019
Compliance and regulatory consulting for management/board

Sep 2022 - Apr 2023

8 months

PAI Inspection Consultant - Auditor

Sanofi ICF Campus Frankfurt

Inspection Readiness Training: Provide site-level guidance to individuals affected by the inspection, focusing on what to expect, how to cooperate with inspectors, and how to prepare
Set up a PAI Readiness Team including quality auditors and relevant management
Assign specific people to answer chemistry, microbiology, facility/processing, formulations, suppliers, and quality-systems-related questions
Review past inspections, responses, and outstanding items
Conduct walk-through examining instruments for calibration status and log books
Prepare lists of commonly requested items: rework/reprocessing events, recalls, product failures, complaints, media fills, deviations, OOS investigations, CAPAs

Sep 2022 - Mar 2023

7 months

QMS Specialist

Heraeus Medevio Global

Integrate CMI QMS of Dresden (HMDD) and Hradec Kralove (HMHK) with the global QMS of HMC

Work Package 1: Document Mapping

Map and understand current QMS structures (CMI QMS and GQMS)
Map CMI QMS docs to HMC global QMS docs
Identify site-specific docs
Create GHMC docs for missing CMI docs and tag obsolete CMI docs
Update GHMC docs for similar but incomplete CMI docs and tag obsolete CMI docs
Tag obsolete CMI docs when equivalent and complete
Update references with new GHMC numbers

Work Package 2: Adoption of GHMC QMS documents into CMI sites

Triage CMI documents to replace with GHMC documents
Map CMI QMS docs to HMC global QMS docs
Create DCRs for new and updated GHMC docs and obsolete CMI docs
Include associated CMI docs in DCRs for reference updates

Oct 2020 - Jun 2022

1 year 9 months

MDR Consultant / Specialist

B.Braun Medical AG + B.Braun Melsungen AG

Strategy development process for MD Class 3 with medicinal substances
Introduction and tasks of the PRRC
Basic structure and requirements for the Technical File (RMF)
Risk management ISO 14971 in Plato
Creation of the development plan
Requirement management: deriving requirements
Responsibility for design verification: methods and their validation, DV planning, pre-testing, DV reporting
General regulatory topics in the area of approval, technical file, and communication with the notified body

Oct 2019 - Sep 2020

1 year

RA & Quality Specialist

Schott AG

Creation of the validation master plan
Creation of the validation concept
Creation of document templates: DQ, IQ, OQ, PQ, VP, VR
Support of validation and creation of the final report
Creation of the validation plan for class 2a products in the PDT area
Creation of the risk analysis
Coordination of preliminary qualification
Evaluation of cleanroom concept for implementing 2a products
Concept for cleaning processes in the cleanroom for medical devices
Concept for manufacturing processes in an ISO class 7/8 cleanroom
Consulting on biological safety requirements of the medical device
Risk management documentation
Technical documentation concept according to EU MDR 2017/745
Evaluation of existing medical devices regarding EU MDR 2017/745 and basic requirements
Review and approve documents in Develop D3

Mar 2018 - Sep 2019

1 year 7 months

Interim Supplier Quality Engineer / Auditor Supplier Audits

Brainlab AG

Creation of an audit process according to ISO 19011
Organization of audit management
Communication with leadership and suppliers
Conducting audits according to ISO 19011
Integration of supply chain with R&D
CAPA closure
Implementation of MDR topics related to supply chain
QSV and contracting
Complaint management
Risk management

Mar 2016 - Jul 2017

1 year 5 months

Interim quality management representative / safety officer under the Medical Devices Act

Roeser Medical GmbH

Responsibility and leadership of quality management according to ISO 13485 and ISO 9001
Additional responsibility under GDP for pharmaceuticals
Audit management
Compliance
Team leadership with 4 employees
Risk management according to ISO 14971
Technical documentation
Supplier management and audits
CAPA and complaint management
Communication with authorities

May 2014 - Sep 2015

1 year 5 months

Interim management expert for Life Sciences

Altran GmbH & Co. KG

Quality management / engineering
Auditing / inspection according to ISO 9001:2008, ISO 13485, 93/42 EEC, 21 CFR 820
Regulatory affairs EU/US
Experience with authorities and FDA
Evaluation and correspondence with notified bodies

Projects:

Roche Diagnostics: method for standards analysis using IBM ReqPro
Novartis AG: strategy and concept for document archiving
Maquet: FDA compliance, support in creating DHF, DMR, QSIT – remediation plan

Jan 2009 - Present

17 years 2 months

Freelancer – TQM auditor for medical devices

Founded the company
Quality management for medical device approval
TQM auditor ©: 478 supplier audits, 13 FDA inspections
Supplier quality engineering / supply chain process
Optimizing and redesigning processes
Implementation and rollout of quality management systems as project manager
Conducting audits (e.g., supplier audits)
Validation of sterilization processes / packaging
Document management

Clients:

B.Braun Melsungen AG, Melsungen (DE)
B.Braun Medical AG, Sempach (CH)
Schott AG, Mainz
Brainlab AG, Munich
Nicolay GmbH, Nagold
Normed Medizintechnik GmbH, Tuttlingen
Thales Deutschland GmbH, Stuttgart
Henke–Sass–Wolf GmbH, Tuttlingen
Klinikum des Landkreises Tuttlingen ZSVA
Novartis Pharma AG, Basel
Synthes GmbH Solothurn

Jan 2007 - Dec 2009

3 years

Validation Quality Engineer

Synthes GmbH Solothurn

Quality management activities for sterile packaging
Conducting risk analyses
Conducting and evaluating packaging validations
Project management for medical implants according to DIN EN ISO 13485:2007
Further development of quality management methods
Insights during surgical operations
Auditing of suppliers

Jan 2001 - Dec 2007

7 years

Electrical Technician

Zellaerosol GmbH

Setting up, changing over, and monitoring packaging, production, and labeling machines for the manufacture of cosmetic and technical products
Responsible for liquid filling operations and aerosol technology in a regulated pharmaceutical environment
Qualification and validation of electronic controls
Quality management
Personnel management
Installation of electrical systems

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Healthcare (19 years), Pharmaceutical (10.5 years), Manufacturing (9 years), and Cosmetics (7 years).

Healthcare

Pharmaceutical

Manufacturing

Cosmetics

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (25 years), Project Management (19 years), Supply Chain Management (17 years), Operations (7 years), Production (7 years), and Product Development (3.5 years).

Quality Assurance

Project Management

Supply Chain Management

Operations

Production

Product Development

Skills

Employee/applicant In Quality Management
Quality Management Division
Project Management / Team Leadership
Career Level: Expert
Auditing
14 Years Of Experience In Quality Management
Process Optimization / Gmp Production
Document Management
Complaint Management
Tools: Ms Office, Html
Methods: Gmp, Capa, Tqm, Fda And Supplier Audits, Din Standards, Qm Tools
Ms Office 2019 (Advanced)
Babtec Caq
Trackwise
Atlassian Confluence
Jira
Sap Q-modules
Qm Gmp
Capa
Tqm Audits
Fda-audits
8d
5s
Ishikawa
Supplier Audits
Din Standards
Other Qm Tools

Languages

German

Native

English

Advanced

Education

Oct 2008 - Jun 2009

IfM Reutlingen

Medical Engineering · Reutlingen, Germany

Oct 2001 - Jun 2007

BA Mosbach

Electrical Engineering · Mosbach, Germany

Oct 1998 - Jun 2001

Müller Martini Druckverarbeitungs-Systeme AG

Energy electronics technician, specializing in plant engineering · Zofingen, Switzerland

Certifications & licenses

FDA Certification

OP Pass Federal Association for Ambulatory Surgery

PRRC According to Article 15 MDR 2017/745

Person Responsible For Regulatory Compliance TÜV Süd

Safety Officer of BG Chemie

TQM Auditor © According to ISO 19011

TQM Auditor ® Healthcare and Social Services

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Benjamin based?

Benjamin is based in Essen, Germany.

What languages does Benjamin speak?

Benjamin speaks the following languages: German (Native), English (Advanced).

How many years of experience does Benjamin have?

Benjamin has at least 25 years of experience. During this time, Benjamin has worked in at least 11 different roles and for 9 different companies. The average length of individual experience is 2 years and 3 months. Note that Benjamin may not have shared all experience and actually has more experience.

What roles would Benjamin be best suited for?

Based on recent experience, Benjamin would be well-suited for roles such as: MDR Transition with PRRC-Function, PAI Inspection Consultant - Auditor, QMS Specialist.

What is Benjamin's latest experience?

Benjamin's most recent position is MDR Transition with PRRC-Function.

What companies has Benjamin worked for in recent years?

In recent years, Benjamin has worked for Sanofi ICF Campus Frankfurt, Heraeus Medevio Global, and B.Braun Medical AG + B.Braun Melsungen AG.

Which industries is Benjamin most experienced in?

Benjamin is most experienced in industries like Healthcare, Pharmaceutical, and Manufacturing. Benjamin also has some experience in Beauty and Cosmetics.

Which business areas is Benjamin most experienced in?

Benjamin is most experienced in business areas like Quality Assurance (QA), Project Management, and Supply Chain Management. Benjamin also has some experience in Operations, Production/Manufacturing, and Product Development.

Which industries has Benjamin worked in recently?

Benjamin has recently worked in industries like Healthcare and Pharmaceutical.

Which business areas has Benjamin worked in recently?

Benjamin has recently worked in business areas like Quality Assurance (QA), Project Management, and Supply Chain Management.

What is Benjamin's education?

Benjamin holds a Bachelor in Medical Engineering from IfM Reutlingen and a Bachelor in Electrical Engineering from BA Mosbach.

Does Benjamin have any certificates?

Benjamin has 7 certificates. Among them, these include: FDA Certification, OP Pass Federal Association for Ambulatory Surgery, and PRRC According to Article 15 MDR 2017/745.

What is the availability of Benjamin?

Benjamin is immediately available for suitable projects.

What is the rate of Benjamin?

Benjamin's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.