Management of MDR transition and quality certificate maintenance, regulatory and clinical strategy development for new products in pipeline, technical Documentation (MDR Annex II and III), Deputy Post-Market Surveillance manager, continuous Improvement, quality assurance and compliance (DIN EN ISO 13485:2021), registered PRRC for TD review and release.

• Medical device registration in EUDAMED and DMIDS for System and procedure packs.
• Audit readiness for QMS and clinical audits, closures with minimal non-conformities.
• Clinical evaluation plans (CEP), biological evaluation plans (BEP), PMCF, and risk management plans (RMP).
• Clinical evaluation assessment reports (CEAR) and biocompatibility evaluation reports (BER), clinical study report (CSR, EMOS register).
• PMS data analysis for Periodic safety update report (PSUR).
• Clinical evaluation assessment report (CEAR) and biocompatibility evaluation report (BER), clinical study report (CSR, EMOS register).
• Vigilance reports (incl. FSCA) in compliance with ISO TR 20416.
• Risk management fi le, process and policy, ensuring compliance with ISO 14971.
• Supported the R&D team with the preparation of FTAs and FMEAs related to design changes, ensuring compliance with relevant standards (ISO 10933, RoHS, REACH, IEC 60601-2-16, IEC 62366, IEC 62304).
• Instructions for use (IFU) (ISO 20417) and labels in accordance with ISO 15223-1

Therapeutic experience:

Haemodialysis therapy (Kidney, Lungs, Liver support)

Medical Devices:

• ADVOS Haemodialysis system (Risk class IIb, active device)
• ADVOS Acidic and alkaline concentrates (Risk class IIb, inactive device)

Regulatory management for first-in-human trial, Clinical study investigation planning, literature review and risk assessment, Study submission dossier preparation, Patient group interaction support.

• Clinical evaluation planning (CEP), Synopsis and Clinical investigation plan (CIP). Systematic Literature review and data extraction plan
• Essential documents in line with ICH-GCP and ISO14155 (Patient informed consent (PIC), eCase report form (eCRF), Scientifi c contribution to the investigators brochure (IB), statistical analysis plan)
• Clinical trial application(CTA), Budget, timeline and resource plan on IRAS portal (UK, UK MDR) and DMIDS (DE, MPDG), for study submissions.
• Consultation meetings with the health authorities (MHRA and BfArM).
• Risk assessments according to DIN EN ISO 14155 and ISO 14971.
• LVAD patients? group feedback meeting.
• Technical documents of the product (IFU, risk assessment report review).
• Regulatory information management by reviewing and evaluating regulations, guidelines and procedures in the current versions of MDCGs.

Therapeutic experience:

Cardiovascular:

• End-stage heart failure

Medical Device:

Mechanical heart assist device (Risk class III, active implant)

Clinical Project Management for RCTs, Product safety, Optimal reimbursement strategy planning, ISO14155 compliance, Study submission dossier preparation, clinical operations,Initiative collaborations with key opinion group leaders.

• Cross-functional research projects in Germany, Switzerland, and the US for Class IIa devices, including leading Kaia's fi rst sponsor trial, AMOPUR, from start-up to close-out.
• Research and clinical study protocols (performance and PMCF) in collaboration with investigators and the chief medical offi cer for clinical and research projects.
• Established study infrastructure, including EDC software, and supported successful DiGA applications and SOPs.
• Led a team of project managers, clinical data managers, biostatisticians, clinical research associates, and part-time students to conduct decentralized clinical studies (USA, DE, CH).
• Market access strategies for Kaia's COPD product in the UK, and collaborated with NHS engagement managers (Chiesi Pharma) to defi ne KPIs and value propositions.
• Clinical studies and research projects, started at Kaia: NCT04290078, NCT04615377, NCT04299165, NCT04411108, NCT04457843, DRKS00024390, DRKS00021828.

Therapeutic Experience:

COPD and MSK

Medical devices:

software medical devices class IIa. SaMD

Clinical project management, Regulatory submissions in DACH region for Pharma and medical device projects, Clinical operation planning and support, essential technical document preparation.

• Actively supported senior project managers in conceptualizing, planning, and executing clinical studies, including regulatory submissions across D-A-CH, UK, and EU/Balkan regions.
• Managed site operations and vendor relationships, facilitating regulatory submissions and monitoring activities to ensure smooth project execution.
• Contributed to clinical research blogs and acted as a liaison with CRO partners, enhancing project effi ciency and compliance.

Therapeutic Experience:

• Neurology:
  • Multiple Sclerosis
• Endocrinology:
  • Menopause (VMS)
  • Prosthetic joint infection
• Gastroenterology: 
  • NAFLD
  • NASH
  • Microscopic Colitis (Phase III-IV)

Assisted with clinical operations and Regulatory submissions in DACH region for Pharma projects, essential technical document preparation.

• Provided outstanding study startup and site operations support for oncology projects in Germany, Austria, and Switzerland, including site feasibility and selection.
• Prepared submission packages (CTD) for ethics committees and authorities, managed notifi cations and amendments, and supported clinical research associates with monitoring visits and study supplies.
• Collaborated with international project managers to organize monitoring and internal audits, ensuring successful pre-study, initiation, and close-out visits.

Therapeutic Experience:

• Oncology:
  • Hematologic Malignancies- Leukemia
  • Myelodysplasia
  • Solid Tumors ? Hepatocellular Carcinoma
• Dermatology:
  • Pemphigus vulgaris (Phase III)
• Pediatrics:
  • Homozygous Familial Hypercholesterolemia (Phase IIb-III)