EU IVDR Experts in Germany
matched in minutes from over 15,000 CVs with the power of AI.Hire experts who know EU IVDR, IVDR transition work, technical documentation, and conformity assessment for in vitro diagnostic medical devices. Get fast, precise matching with vetted, available freelancers.
Meet FRATCH Experts in Germany, who have recently used EU IVDR
Sascha Mondon
Last position:
Senior Director Lab Transformation (CEO Office) at Amedes Group
- Leading the group's transformation program task force on behalf of the CEO and representing the CEO at the sites on operational and transformation executive managerial matters
- Operational & (digital) transformation advisor to the CEO
- Operational stabilisation of the group during a group-wide Operational Excellence and Lean transformation program consisting of process improvement, digitalisation and sourcing consolidation
- Increasing efficiency through automation and AI application in close collaboration with the CIO
- Improvement of the central IT, Finance and HR departments
- Management of the OpEx Teams and advisor to the VP Operational Excellence
- Stakeholder management of shareholders, business entities and employee representatives
Patricia Afonso Alemany
Last position:
Head of Operations at StratifAI GmbH
- Designed, managed, and implemented the company’s operational, compliance, procurement, and financial strategy, ensuring alignment with rapid scaling and regulatory objectives.
- Built and scaled operational infrastructure across IT, HR, Finance, Procurement, and Compliance, supporting growth from 4 to 20 team members in 6 months.
- Oversaw financial management of OPEX, including budgeting, monitoring, and cost optimization to sustain high-growth operations.
- Developed and executed a procurement strategy, including vendor selection, negotiation, and performance oversight.
- Procured and managed external consultants (compliance, quality, regulatory experts) and orchestrated collaboration across internal teams and external partners to meet milestones.
- Implemented policies, SOPs, and business systems (compliance tracking, eQMS, payroll, vendor management, data governance) to support regulatory compliance and scalability.
- Managed and actively oversaw regulatory and compliance programs, embedding GDPR, HIPAA, SOC 2, ISO 27001, and ISO 27701 requirements into day-to-day operations.
- Directed the rollout of a Quality Management System (QMS) aligned with ISO 13485 to prepare for medical device and AI regulatory certifications.
- Led people and culture development, establishing onboarding, performance management, and cross-functional collaboration structures to scale the organization effectively.
- Established risk management and business continuity frameworks, including security controls, risk registers, and compliance safeguards.
- Engaged executive leadership, board, and investors to align operational strategy with corporate goals and market expansion.
- Enabled technology-driven operations, selecting and implementing digital systems (e.g., Drata, Qualio) to ensure compliance and efficiency.
- Scaled StratifAI’s operational backbone to support rapid growth and international market readiness.
- Achieved ISO 27001, ISO 27701, SOC 2, GDPR, and HIPAA compliance within 6 months, enabling enterprise and healthcare partnerships.
- Implemented a QMS system aligned with ISO 13485, paving the way for regulatory approvals and positioning for upcoming ISO 13485 certification, CE-IVDR marking, and FDA clearance within 12 months.
- Designed and executed governance, procurement, and financial controls, ensuring efficient resource allocation and sustainable compliance.
- Established a culture of structured growth, integrating people, processes, and compliance frameworks to maintain operational excellence.
- Enabled StratifAI to confidently enter regulated US and EU markets, building the foundation for long-term expansion.
Reza Moini
Last position:
Head of IT Operations at Centogene GmbH
- Advanced to directly report to C-level and lead the €1.5M budget with AWS, utilizing S3, EC2, and RDS services to run 21 accounts, 5 OUs, and 3 PB of data by architecting the AWS environment and monitoring KPIs.
- Led a strategic cloud migration from legacy systems to AWS, reducing data center costs by 42% annually. Designed and executed the transition plan, including refactoring and rehosting operations, ensuring system compatibility, and optimizing infrastructure connectivity.
- Reduced external firewall costs by €204k per month by eliminating the external service provider and bringing the function in-house, advertising on LinkedIn, screening candidates and leading the interviews.
- Lowered mobile phone costs from €276k to €60k for 300 users on 2-year contracts by negotiating better tariffs with Vodafone, removing unnecessary services for each user and standardizing across all countries.
- Saved €45k per annum by eliminating infrastructure and external IT consultancy costs in Zug, Belgrade, Berlin and Boston by reviewing the services, conducting a risk assessment and building an in-house team.
- Increased payment terms from 30 to 180 days with the four main suppliers which generated an additional €280k per month into the business by persuading them to support the company during a difficult period.
Andreas Ayukebi
Last position:
Senior Medical Director at Biogen International
- Led and supervised the development of publication content within a large neurodegenerative disease, increasing scientific impact and brand visibility.
- Collaborated with an international team and account to ensure the accuracy and effectiveness of medical communications materials.
- Oversaw the strategic planning and execution of key attendance at conferences, resulting in increased engagement with healthcare professionals.
- Contributed to Global Medical Affairs strategies, policies, and programs, and drove implementation in the international region.
- Supported the launch of new and marketed products by generating and disseminating scientific and clinical evidence, both internally and towards key external stakeholders.
- Responsible for Investigators Initiated Studies (IISs) and Non-Interventional Studies (NISs).
- Established and managed relationships with relevant KOLs, influencers, societies, associations, and prescribers, and facilitated appropriate contacts across the region.
- Developed, coordinated, and conducted external education and training for MDs, caregivers and patients, and customer support groups in line with the Medical Affairs plan.
- Provided expertise in the evaluation of complaints and adverse events.
- Worked closely with Public Affairs to align scientific and medical society support for patient advocacy initiatives.
- Educated the internal Shire community through partnering on content development and delivery of medical training, ensuring field teams have the clinical knowledge to effectively support the therapy at a local level.
- Provided medical input to marketing and product launches.
- Worked with International GBU and Therapy Advisory Board to develop the network of local country Shire MDs in the therapeutic area/business, leveraging best practices and expertise across the region, and provided medical input into product launches.
- Provided expertise on neurovascular protocol review to support global studies and programs.
- Developed medical strategies for study protocols and supported medical affairs initiatives.
- Responsible for the promotional and scientific materials review and approval.
- Led CCSM team engagements with clinical sites for therapeutic programs.
- Conducted protocol training for CCSLs in assigned Phase II/III/IV studies.
- Integrated and aligned clinician engagement strategies with therapeutic programs.
- Served as an escalation point for clinical/medical protocol issues.
- Collaborated on a multi-year global medical strategy aligned with product/R&D strategies.
- Managed safety data review, signal detection, and communication across development phases.
Monika Weber
Last position:
Quality Specialist at Nexans GmbH
- Implementation of a quality management system including creating all required process descriptions and work instructions for ISO 9001:2015 certification, as well as final planning and conducting audits
- Creating action catalogs for measures needed to comply with ISO 9001 and achieve the targeted certification
- Preparing documentation related to ISO 9001
- Developing training materials for employees and managers based on the QMH and the created documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) according to ISO 9001
- Preparing for and participating in certification audits
Niels Adams
Last position:
Consultant: Translational Sciences at Large Pharma
- Authoring biomarker planning documents, biomarker manuals, research and development reports
- Review of clinical trial and vendors’ biomarker reports
- Development of standard operating procedures and interdepartmental training materials
Juergen Mehring
Last position:
Freelancer at Mehring Consulting
- Senior Consultant Regulatory Affairs; Medical Devices
- Certified Lead Auditor EN ISO 13485
- Certified Information Security Officer according to ISO/IEC 27001
- Certified Lead Auditor ISO/IEC 27001
- Trainer
- Approval strategies, national and international, project management
- Classification of medical devices; all risk classes of medical devices (active and non-active), IVD devices, especially borderline products
- creating development-supporting and technical documentation for medical devices, editing existing technical documentation
- review and updating of existing quality management documentation or creating new required quality documents
- Assistance during the CE and international approval process for medical devices, including IVD medical devices
- Preparation and review of technical files; compliance with regulatory and legal requirements
- Serious Incident and Field Safety Corrective Action (Recall) reporting; correspondence with the competent authorities within the EEA
- Implementation of Quality Management System (EN ISO 13485)
- Quality Remediation
- MDR / IVDR Remediation
- Project and Risk Management
- Implementation of UDI requirements
- on-site seminar according to the individual requirements
- good relationships to notified bodies and competent authorities
Lars Behrend
Last position:
Owner at LifeTech Consult
- Corporate finance advisor and strategic consultant to startup companies
- Technical analyst for investors
Discover over 15,000 top freelancers
Statistics of experts using EU IVDR
Aggregated from the professional profiles of matched freelancers.
Experience
21 years
Position duration
3.3 years
Positions per freelancer
11
Top business areas
Project Management, Quality Assurance, Operations
Top industries
Healthcare, Biotechnology, Education
Certification focus areas
Quality Assurance, Research and Development, Business Intelligence
Bachelor's degree or higher
100%
Master's degree or higher
57%
Doctorate
43%
Certifications per freelancer
4
Most common languages
English, German, French
Speak two or more languages
100%
Based on our profile pool as of 30 Aug 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Germany are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range.
Average rates of experts in Germany using EU IVDR
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
What it covers
EU IVDR is the EU rule set for in vitro diagnostic medical devices. It shapes how tests are classified, documented, assessed, and kept compliant across the product life cycle. Companies use it for new product launches, legacy transition work, and updates to technical files.
Typical work
- Gap assessments against IVDR requirements
- Technical documentation and performance evidence
- Classification and conformity strategy
- PMS, vigilance, and UDI-related support
- Transition planning for legacy IVDs
Skills that matter
Strong specialists combine regulatory judgment with clear document control. They know Annex II and Annex III, performance evaluation, risk management, labeling, and interactions with notified bodies. They also understand how evidence, claims, and intended purpose must align.
Tools and files
In practice, the work sits inside QMS processes, document templates, traceability matrices, and submission packages. Specialists often work with risk files, clinical and performance evidence, change logs, and supplier records. Good structure matters because reviewers need a clear chain from claim to proof.
When to bring in help
Companies usually bring in freelance experts when deadlines are tight, internal teams lack IVDR depth, or a project has reached a difficult transition point. That is common for manufacturers in Germany, especially when teams need support in English and German or need an outside review before a notified body step.
What strong experts do
They do more than fill templates. They spot weak claims, missing evidence, unclear intended use, and inconsistencies across the file. The best specialists keep the work practical, defendable, and ready for review by quality and regulatory stakeholders.
Frequently asked questions
The facts hiring teams ask for most often when it comes to EU IVDR.
EU IVDR is the European rule set for in vitro diagnostic medical devices. It governs how tests and related systems are classified, documented, assessed, and maintained after launch. Companies use it to support new product development, legacy transition work, and ongoing compliance.
No. IVDR replaced the older IVDD framework and is generally stricter on evidence, classification, and lifecycle control. If a product still sits on an IVDD transition path, a specialist should check the current status and the evidence gap carefully.
A EU IVDR freelancer is often brought in for gap assessments, technical documentation, performance evaluation, and notified body preparation. Other common tasks are transition planning, PMS support, and review of claims or labeling. This is useful when an internal team needs focused help rather than a full-time hire.
A strong EU IVDR specialist usually also knows ISO 13485, risk management, performance evaluation, and quality management system work. Familiarity with UDI, vigilance, and document control helps a lot. For Germany-based teams, clear communication in English and often German is valuable too.
That depends on the scope. A document review may need a focused specialist, while a transition program, classification challenge, or notified body preparation usually needs deeper IVDR experience. The key is proven work on similar files, not a general regulatory background.
EU IVDR is specific to in vitro diagnostic medical devices, while MDR covers other medical devices. The two frameworks share some quality and lifecycle concepts, but IVDR places special emphasis on performance evidence and test-specific claims. A specialist should know where the rules overlap and where they do not.
Yes, most EU IVDR work can be done remotely, especially document review, strategy, and technical file preparation. On-site time can still help during workshops, audits, or stakeholder alignment. For German teams, remote collaboration is common as long as the language needs and review process are clear.
Look for specific work on EU IVDR files, not just general regulatory language. Good specialists can explain classification logic, evidence gaps, and the link between intended purpose, claims, and documentation. Ask for examples of similar projects, review methods, and how they handle change control and review feedback.
The average hourly rate of freelancers in Germany who have used EU IVDR in their recent projects is 142 €, which corresponds to a daily rate of about 1,139 € based on an 8-hour working day.
Of the freelancers in Germany who have used EU IVDR in their recent projects, 100% hold at least a Bachelor's degree, 57% hold at least a Master's degree, and 43% hold a doctorate.
On average, freelancers in Germany who have used EU IVDR in their recent projects have 21 years of professional experience, with a single engagement typically lasting around 3.3 years.
The most common languages among freelancers in Germany who have used EU IVDR in their recent projects are English (100%), German (88%), and French (38%).
The most common industries among freelancers in Germany who have used EU IVDR in their recent projects are Healthcare (100%), Biotechnology (75%), and Education (63%).
The most common business areas among freelancers in Germany who have used EU IVDR in their recent projects are Project Management (100%), Quality Assurance (75%), and Operations (63%).
Main locations of FRATCH Experts, who have recently used EU IVDR
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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Philipp Thomaschewski
FRATCH CEO
