Pre-selected consultants
for Sophion Bioscience
At Medicologic we take great pride in providing top-class consultants to the medical industry. We are partners with some of the most skilled consultants in the industry – setting the level of standards and deliveries as high as possible.
In this consultant-portal, we have selected a line of consultants with potential interest for the projects and tasks at Sophion Bioscience.
Engineering
Medical Device R&D Expert (ID1014)
Competences:
- Excellent task force leader with ability to provide clarity in complex and multidisciplinary problems.
- Product Verification and Validation.
- Deep understanding of regulatory requirements including design controls (ISO 13485), risk management (ISO 14971) and IEC 60601-1.
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Senior Consultant Medical Device (ID1018)
Competences:
- Management and project management.
- Design and implementation of QMS.
- Design Controls and DHF.
- Testing Strategies and Implementation.
- Implementation of the V-model.
- Design verification.
- Medical Device Files.
- Risk Management.
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Qualification and Validation (ID1020)
Competences:
- Qualification and validation (process/method/software).
- Risk Management.
- Process validation.
- Software and Method validation.
- Equipment qualification.
- Six Sigma (trained master black belt).
- Applied statistics.
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R&D Program Management and Design Control (ID1022)
Competences:
- Medical Device Development.
- Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments.
- Mechanics, electronics, software and connectivity.
- Design Control and QA:MDR, ISO 13485, 21 CFR820.30.
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Combination Product Developer (ID1024)
Competences:
- Project Management
- Medical Device Testing Strategies and Implenentation
- Management of R&D projects and R&D teams
- Concept and idea generation
- Drug-Device combination products
- Device troubleshooting.
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Senior Product Development Engineer (ID1027)
Competences:
- Injection moulding.
- 2D and 3D part and assembly documentation.
- Design control.
- Research and Development.
- Validation, testing and packaging.
- Test setup and test planing.
- Project leading.
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Thermoplastic Specialist (ID1035)
Competences:
- Specialist in selecting thermoplastic raw materials.
- Handled more than 2.500 thermoplastic raw materials.
- Raw materials for Medical Devices.
- Testing and qualifying raw materials.
- Co-operates with test laboratories globally.
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Materials and Surface Applications (ID1039)
Competences:
- Materials selection, and Surface modifications, including supplier assessment, aimed for Medical Device products Class II.
Regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings
(ISO10993-*) and IEC 60601-1
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Safety Connected Devices (ID1050)
Competences:
- Medical Device and IVD compliance.
- Risk analysis, FMEA, FMECA.
- Device safety and security standard specialist.
- EMC design/test at board & system level. EMC standards & compliance.
- Signal analysis / processing
- RFID, NFC
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Senior RA/QA Software Specialist (ID1059)
Competences:
- Medical devices regulatory compliance (MDR)
- In vitro devices regulatory compliance (IVDR)
- Software as a medical device
(SAMD) - Cyber security
- Verification and Validation
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Senior Chemistry Consultant (ID1060)
Competences:
- Verification & Validation, Laboratory testing
- Quality Assurance, Medical Devices
- Audit Manag., Internal Audits,
ISO 13485 - Nonconformance and CAPA Management
- HACCP and traceability documentation
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Senior R&D Consultant (ID1064)
Competences:
- Diagnostics – ‘Point-of-Care’
- Microfluidics
- Sensor development and integration
- Apparatus construction
- Industrial design
- Surface chemistry
- Biochemistry
- Laser machining (CO2, Excimer)
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Scientific
QA and RA, Medical Device Expert (ID1008)
Competences:
- Project management; Prince2 certified.
- Design control, requirements, design gates.
- Verification, production transfer, validation.
- Quality management.
- Risk management.
- Design FMEA.
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Qualified Person (QP), API release (ID1029)
Competences:
- NC/CAPA Process management.
- Systematic problem solving (Coaching).
- Change request process management.
- Validation Activities (URS, Equipment Qualification, and process Qualification).
- QP (Batch review and product release).
- QMS implementation (procedures/templates).
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Principal Advisor Pharma Development (ID1046)
Competences:
- More than 30 years of experience from the pharmaceutical industry hereof 14 years’ experience from RA CMC.
- Managerial experience within RA CMC.
- Writing of CTA/INDs for clinical trial applications for Phase I-III.
- Experience with Q&A phases for CTA/IND/NDA/BLA/MAA approvals.
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Senior Specialist Pharma Production (ID1047)
Competences:
- Project Management.
- Establishment of strategy concerning calibration of instrumentation including for calibration points and frequency.
- Handling of GMP and quality assurance in general including change control and deviations.
- Handling of strategy plan concerning.
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Senior Consultant, Medical Device Compliance (ID1048)
Competences:
- Design Control.
- Risk Management.
- CAPA.
- Design validation.
- Human Factors / Usability.
- Requirement Engineering.
- SAMD/SIMD/MDSW.
- Customer complaint investigation.
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Graphical Design and Digital (ID1054)
Competences:
- Print and digital
- Campaign and communication
- Brand protection
- CVI
- Infographics
- Image retouche
- Digital strategy
- Facilitating photoshoots
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Senior Qualification & Validation Expert (ID1065)
Competences:
- CQV packages – URS, CARA, DQ, FAT, SAT, IQ, OQ, PC/PJ/PFV/PV), CV and CM.
- Risk assessment + FMECA
- SME in Process Cleaning of multipurpose and dedicated facilites
- QA and product release.
- GMP, GdocP
- Deviation handling
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Compliance
Toxicology and Biosafety (ID1001)
Competences:
- Regulatory toxicology and product safety.
- Biological Evaluation Report.
- Clinical Evaluation Report.
- Medical Writer.
- Biological Evaluation Plan.
- Toxicological exposure and safety assessment.
Learn more >>>
Clinical Evaluation and Biosafety (ID1002)
Competences:
- Risk analysis and safety assessment.
- Clinical evaluation.
- Multi-disciplinary project management.
- Post-Market Clinical Follow-up (PMCF) plan and reports.
- Strategic planning and execution of activities supporting industry board goals.
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QA / RA expert, Medical Device (ID1004)
Competences:
- Project management.
- Quality management.
- Management Representative.
- Gap Analyses.
- Quality systems implementation.
- Design Control.
- Design Dossiers and Technical File forCE marking.
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QA Expert with experience in regulatory affairs (ID1007)
Competences:
- Project Management.
- Executive Management, Strategy.
- Quality Management Systems ISO 9001, ISO 13485.
- Design Control and MDR transition.
- Clean Room, Health and Hygiene and ETO-Sterilization.
- Process-and sterilization validation.
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Management and change management (ID1016)
Competences:
- Management.
- Change Management.
- Quality Management and
- Implementation.
- IT-system for QA.
- Process optimizing.
- Process validation.
- LEAN.
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Senior Consultant Medical Device (ID1018)
Competences:
- Management and project management.
- Design and implementation of QMS.
- Design Controls and DHF.
- Testing Strategies and Implementation.
- Implementation of the V-model.
- Design verification.
- Medical Device Files.
- Risk Management.
Learn more >>>
Validation Specialist, Techno-logy and Chemestry (ID1019)
Competences:
- Lead Validation.
- Senior CQV Engineer.
- Risk Assessment.
- Process and Cleaning Validation.
- QA Validation.
- Quality Assurance.
- CAPA and Compliance.
- Qualification and Validation.
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Principal Advisor Medical Device QA/RA (ID1028)
Competences:
- ISO13485 Medical device lead auditor.
- QMS management: ISO13485, FDA 21 CFR part 820 and In vitro diagnostics and medical device regulations (MDR/IVDR).
- GMP and Quality Assurance (QA).
- CAPA and non-conformance handling.
- Process-and test method validation.
- Risk management.
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Senior Consultant, Medical Device Compliance (ID1048)
Competences:
- Design Control.
- Risk Management.
- CAPA.
- Design validation.
- Human Factors / Usability.
- Requirement Engineering.
- SAMD/SIMD/MDSW.
- Customer complaint investigation.
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Senior Consultant Biochemistry (ID1051)
Competences:
- 20+ year experience in pharmaceutical industry as chemical engineer
- Technical Chemical Trouble Shooting within manufacturing industries
- Product process optimization
- Preparation/assessment of technical documentation
- Management of R&D and QC labs
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RA/QA Expert, Medical Device (ID1058)
Competences:
- Quality management, Management representative and Gap Analysis
- PRRC (MDR) & EU authorized rep.
- Executive management,
strategy - Trained Lead auditor; supplier audits, internal audits
- Risk Management, CAPAs
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Senior Chemistry Consultant (ID1060)
Competences:
- Verification & Validation, Laboratory testing
- Quality Assurance, Medical Devices
- Audit Manag., Internal Audits,
ISO 13485 - Nonconformance and CAPA Management
- HACCP and traceability documentation
Learn more >>>
Senior Compliance and Audit Consultant (ID1063)
Competences:
- Quality Management
- Medical Device QMS and implementation
- In- and external audit and inspection
- Audit Management and execution
- Supplier Quality Management and audit
- Quality tools, i.e. CAPA, NCR, MR
- Lead auditor
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Senior RA Expert MD and IVD (ID1066)
Competences:
- Regulatory Affairs Certified (RAC)
- Certified PR 365: MD-QMS ISO 13485:2016
- Medical Devices and In Vitro Diagnostics products registrations
- Vigilance
- Change Control
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Audit
QMS & Supplier Quality Expert (ID1031)
Competences:
- Supplier Management.
- Quality Management.
- Audit Management.
- Trained lead auditor/
internal auditor. - Team/Department management.
- Management representative.
- Quality system implementation.
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Quality Management and Regulatory Affairs (ID1005)
Competences:
- Management/Project Management.
- In-depth knowledge of Quality Management Systems World Wide (ISO 9001 / 13485, CMDCAS, MDSAP, Taiwan, TGA & 21CFR820).
- In-depth knowledge of establishing, maintaining and certification of Quality Management Systems.
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Senior Consultant Audit and Validation (ID1025)
Competences:
- Qualified Lead auditor with notified body experience for:
Medical Device Regulation 2017/745 (MDR). - MDSAP.
- Medical Device Directive 93/42/EEC.
- ISO 13485:2016.
- ISO 9001:2015.
Learn more >>>
Senior QA & Compliance Expert (ID1033)
Competences:
- Audit Process Management.
- Inspection Readiness.
- Active & Certified Lead Auditor; external/internal audits.
- Gap Analyses Expert.
- Root Cause & Investigations SME.
- Quality Management | QMS elements.
- Supplier Quality Management.
Learn more >>>
Clinical
Senior Clinical Compliance Expert (ID1003)
Competences:
- Clinical compliance (MDD).
- Clinical compliance (MDR/IVDR).
- Clinical trials and GCP.
- Clinical Evaluations.
- Expert insight within the healthcare sector.
- Business innovation on the basis of science and research.
Learn more >>>
Senior Clinical Compliance Consultant (ID1062)
Competences:
- Project management
- Clinical evaluations
- Clinical compliance (MDR/IVDR)
- Clinical trials and GCP
- Clinical investigations and GCP
- MedTech R&D development
and launch - ISO 14155, 13485 and 14791
Learn more >>>
Clinical Evaluation and Biosafety (ID1002)
Competences:
- Risk analysis and safety assessment.
- Clinical evaluation.
- Multi-disciplinary project management.
- Post-Market Clinical Follow-up (PMCF) plan and reports.
- Strategic planning and execution of activities supporting industry board goals.
Learn more >>>
Toxicology and Biosafety (ID1001)
Competences:
- Regulatory toxicology and product safety.
- Biological Evaluation Report.
- Clinical Evaluation Report.
- Medical Writer.
- Biological Evaluation Plan.
- Toxicological exposure and safety assessment.
Learn more >>>
Project Management
R&D and Design Control (ID1043)
Competences:
- Program and project management.
- Radiology software, endoscopes, hearing implants, autoinjectors, IVD point of care testing including reagents.
- Mechanics, electronics (IEC 60601 series), software (IEC 62304) and connectivity.
- Design Control and QA: MDR, IVDR, ISO 13485, 21 CFR 820.30.
Learn more >>>
Senior Consultant Project Management (ID1049)
Competences:
- Project and Program Management within Operations and R&D
- Create overview and transparency in complex projects
- Broad business understanding
- Project implementation in Operations
- Solid knowledge of implementation and maintenance of ERP systems
Learn more >>>
Medical Device Manufactoring (ID1052)
Competences:
- Medical Device Production Development
- Project Management
- Verification, product transfer,
validation - Product management
- Quality management
- Risk management
- MDR
- Learn more >>>
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.