Enjoy exclusive access to leading talent updates - Browse our latest Adaptive approved ? Medtech candidates. Candidates are interviewed and placed quickly, if you are interested in any of the candidates, send us a message on LinkedIn or email [email protected] today.
Senior Regulatory Affairs Manager - 181057
- Bachelor’s and Master’s of Science in Biomedical Science
- PRRC with 7+ years in RAQM for medical devices (software, AI, and drug-device products)
- Risk management (ISO14971), QMS development and Lead Auditor for MDSAP, ISO13485 and FDA CFR Part 820
- Native German
- Fluent English
IVD RAQM Manager - 298667
- Master’s in Biomedical Engineering with a specific focus on Regulatory Affairs for medical devices / in-vitro diagnostics
- Almost 4 years of experience in working with Class III orthopaedic implants and IVDs as a Regulatory Affairs Manager
- Designed a UDI-system
- Fluent German
- Fluent English
Head of Regulatory Affairs - 458289
- Bachelor’s degree in Microbiology
- Master’s of Business Administration
- Ph.D. in Microbiology
- 10+ years of experience in Regulatory Affairs
- Skilled in maintaining technical documentation with regulatory authorities
- Fluent German
- Fluent English
RAQM Specialist / Manager - 264051
- Bachelor’s degree in Technical Physics
- Master’s degree in Biomedical Engineering
- 3.5 years of experience in Regulatory Affairs and Quality for medical devices (including medical software apps)
- Responsible for the creation and maintenance of technical documentation under MDD/MDR
- Fluent German
- Fluent English
Junior RAQM Specialist - 338619
- 2+ years of experience in Regulatory Affairs
- Knowledgeable in Quality Management System ISO 13485
- Skilled in creating & managing Technical Documentation
- Familiar with the Medical Device Regulation (MDR) 2017/745
- Fluent English
- A1 German
Quality Assurance Manager - 337262
- PhD, MSc & BSc in Chemical Engineering
- 9 years in Quality Assurance and Quality Control within the MD and pharmaceutical industries
- Quality Management Systems (QMS) Implementation
- Managed a team of three Quality Assurance Specialists, overseeing workload to meet business deadlines.
- Established and maintained quality management systems (QMS) compliant with ISO 9001, ISO 17025, ISO 13485, and 21 CFR Part 820.
- Reviewed and approved change controls, deviation reports, failure investigations, and risk assessments.
- Trained clients on industry compliance standards.
- Led a team of four Quality Assurance Specialists, coordinating work to meet business needs.
- Reviewed GMP documents and approved validation documents (IQ/OQ/PQ), as well as stability data and sampling protocols.
- English: Fluent
- German: Fluent
Quality Engineer - 267446
- Graduate Engineer, Mechanical Engineering
- 9 years in Quality Assurance and Quality Control within the MD and pharmaceutical industries
- Quality Management Systems (QMS) Implementation
- Managed a team of three Quality Assurance Specialists, overseeing workload to meet business deadlines.
- Established and maintained quality management systems (QMS) compliant with ISO 9001, ISO 17025, ISO 13485, and 21 CFR Part 820.
- Reviewed and approved change controls, deviation reports, failure investigations, and risk assessments.
- Trained clients on industry compliance standards.
- Led a team of four Quality Assurance Specialists, coordinating work to meet business needs.
- Reviewed GMP documents and approved validation documents (IQ/OQ/PQ), as well as stability data and sampling protocols.
- English: Fluent
- German: Fluent
- Master of Science (MSc) in Industrial Engineering and Mechanical Engineering
- 6 years of experience (4 years as Risk Manager)
- Support and development of risk management processes over the entire product life cycle.
- Moderation and documentation of risk management elements according to ISO 14971:2019.
- Global training and process implementation for risk management processes.
- Project planning for pharmaceutical production facilities and technical projects.
- Development and optimization of manufacturing processes.
- ISO 14971 Risk Management and Risk Analysis for Medical Products according to ISO 14971.
- Advanced skills in MS Office, Plato e1ns, Polarion, Jira, and Q-das/Solara.
- German: Native
- English: Fluent
- Master of Science (MSc) in Sensor System Technology
- 4+ years in medical device development
- Development of medical devices following IEC 62304 standards.
- Writing requirements, architecture, design, and testing documentation.
- Supporting testing and test management for medical software devices (unit and integration testing).
- Programming with MATLAB and C for various innovative digital projects.
- Worked on robotic sensors, programming in C++.
- C++, Embedded C, MATLAB, Python, R, LabVIEW
- Experience with microcontroller boards (MSP430, STM32, dsPIC33EV)
- C Programming for Embedded Systems
- C++ and Python Programming Certificate
- English: Fluent
- German: Professional
Software Developer - 437253
- Master of Science (MSc) in Physics
- 9 years in software development in the medtech
- Solely responsible for the development of IVD device software.
- Conceptual design and architecture of software.
- Software implementation (C/C++ for MCU, C# for GUI).
- Deployment to embedded hardware (PC).
- Standards-compliant documentation (IEC 62304, IVDD, ISO 13485).
- Requirements engineering and development of test plans.
- Development of tools for production and service pipeline.
- Support product management and sales (conference presentations).
- Advanced: C, C++, C#, .NET, Embedded Development, Linux (Debian, Ubuntu), UML, IEC 62304, ISO 13485, IVDD
- Good: ASP.NET, Blazor, Xamarin, Python, Java, Lua, Ruby, SQL, MongoDB, Microcontrollers (Atmel, STM, Espressif)
- English: Fluent
- German: Native
External Audit Specialist - 415532
- Master of Science (MSc) in Biomedical Engineering
- 5 years of experience in Quality Management for Medical Devices.
- Skilled in internal and external audits, technical documentation, and regulatory compliance.
- Holds an MSc in Biomedical Engineering.
- Fluent in English and native in German.
- Maintenance and development of the quality management system according to DIN EN ISO 13485, MDR, and CFR 820
- Planning and performance of internal audits according to DIN EN ISO 13485, MDR, and MDSAP
- Developing and implementing a quality management system in accordance with ISO 13485 and ISO 14971
- MDSAP, 21 CFR, ISO 14971 & CAPA
- MBA in Medical Devices and Healthcare Management
- 4 years of experience in managing medical device product development projects.
- Holds an MBA in Medical Devices and Healthcare Management and a B.Eng in Design and Development Engineering.
- Proven track record in product lifecycle management, market analysis, and optimizing product portfolio pricing.
- Successfully initiated and managed three product development projects and two product enhancements
- Launched a new product, achieving 10% market penetration within twelve months
- Optimized product portfolio pricing, resulting in a 7% increase in cross-profits
- Coordinated product demonstrations and testing for prospective customers
- Supported trade shows and industry events, representing the company
- Completed extensive sales training and gained in-depth understanding of medical device products
- Implemented design improvements and modifications to existing medical devices
- Collaborated with cross-functional teams to develop and prototype innovative medical devices
- German: Native
- English: Fluent
- French: Advanced
Quality Management Representative - 412453
- Engineering Degree (Diploma) in Physics
- Over 25 years of experience in leadership roles within the Medical Device Industry.
- Expert in implementing FDA, MDR, and ISO 13485 standards into QMS.
- Skilled in internal and external audits, CAPA, and regulatory compliance.
- Holds an Engineering Degree in Physics.
- Responsible for vigilance and maintenance of safety cases products
- Development and maintenance of a quality management system according to MDR, ISO 13485:2016, and MDSAP
- Leading internal and external audits, CAPA, training, and regulatory compliance
- Team leader for the central quality management department
- Quality Management Systems (QMS)
- CAPA
- German: Native
- English: Fluent
Research & Development Engineer - 467867
- Master’s Degree in Bioengineering
- 2 years of experience in cardiovascular medical devices.
- Proficient in CAD systems (SolidWorks), tensile and fatigue testing, and prototype development.
- Holds a Master's and Bachelor's degree in Biomedical Engineering.
- Experienced in maintaining QM systems according to ISO 13485.
- Development of new parts design using CAD systems (e.g., SolidWorks)
- Responsible for test methods and setups to assess safety, functionality, and reliability of devices
- Conducting tensile and fatigue testing of implants and components
- Production of new prototypes
- Experience with Class 8 clean room environment
- Regular equipment qualification and calibration
- CAD design (SolidWorks)
- English: Fluent
- German: Fluent
UX/Usability Expert - 284564
- Certified Usability Engineer
- Extensive experience in UX design, usability evaluations, and quality assurance for medical devices.
- Proficient in IEC 62366 and FDA guidelines, prototyping, and requirements engineering.
- Holds a certification in Usability Engineering.
- Quality Assurance
- Introduced usability engineering process into company structure
- Usability according to IEC 62366 and FDA guidelines: planning, implementation, and documentation of usability evaluations
- Prototyping during development (UI/UX design)
- Creation and maintenance of the usability file
- Planning, conducting, and documenting usability evaluations
- Prototyping (hardware/UI/UX design)
- Creation and maintenance of usability files
- English: Fluent
- German: Fluent
Candidates are interviewed and placed quickly, if you are interested in any of the candidates, send us a message on LinkedIn or email [email protected] today.
