SJ

Susanne Jäkel

partly available

Last update: 17.10.2023

Freelancer (IVD In vitro diagnostics) Regulatory, Quality Management

Company: Susanne Jäkel
Graduation: not provided
Hourly-/Daily rates: show
Languages: German (Native or Bilingual) | English (Full Professional) | Italian (Limited professional)

Attachments

2021 06 01 CV Susanne Jaekel GBR.pdf

Skills

ISO 13485, ISO 14971, IVDR, IRCA Certified Lead Auditor ISO 13485 and MDSAP, Technical Dokumationen, In Vitro Diagnostics, Class A, Class C, Hämatology, Immunology, Nephrology, Urology, Laboratory Diagnostics, Labordiagnostic, In Vitro Diagnostik, Risikomanagement, Risk Management

Project history

02/2018 - 12/2020
Director of Product Management and Marketing and Regulatory Affairs
Abviris Deutschland GmbH

- Building up and heading the Marketing and Product Management team (Immune Oncology, POC
tests and ELISA for detecting and monitoring cancer)
- Responsible for Regulatory Affairs and supervising QM personnel and activities
- Defining and controlling of budgets
- Responsible for annual marketing plans and setting up campaigns
- Initiating the introduction of digital QMS tools and realization the transfer in the company
- Reviewing technical documentation for submissions, including the writing and support of
compiling risk management reports according to ISO 14971, IEC 62366
- Writing validation protocols and master validations plans according to CLSI guidelines
- Coordinating market access projects and product launches
- Regulatory responsibilities associated with the development, support and manufacturing of IVD
("others" under the IVDD, class A and C under IVDR), RUO
- Responsible for documentation and coordination needed for monocenter and multicenter
scientific and performance studies and coordinating FDA submissions considering GCP, MPG
and ISO 20916
- Performing internal audits and preparing Management Review meetings

03/2015 - 01/2018
Product Marketing Manager Global Project Group "Flowcytometry Reagents
SYSMEX EUROPE GmbH

- Strategic development of new business "Clinical Flow Cytometry"
- Defined, recommended and implemented marketing strategies for global and EMEA markets
- Planned and budgeting marketing activities
- Initiated adaptation of organizational processes in SCM and SAP to enable e-commerce for a new
business segment
- Prepared documentation for IFU-capability, labels for upcoming products for research, IVD
diagnostic testing according to guidelines as IVDR, MDR
- Setup performance evaluations for diagnostic products to meet product standards as a

requirement for self-declaration
- Compiled technical files and STED defined by ISO, European, and local guidelines

04/2009 - 02/2015
Marketing Manager Diagnostic Concepts, Scientific Marketing EMEA
SYSMEX EUROPE GmbH

- Cross-disciplinary coordination of marketing activities in EMEA, including business cases
- Managed KOL in the EMEA region
- Project manager for several special projects (teams up to 5 persons)
- Developed SPM concepts; coordinated marketing campaigns
- Initiated and implemented scientific studies

04/2001 - 03/2009
Product Manager EMEA
SYSMEX EUROPE GmbH

- Product lifecycle management, supported national marketing and sales activities, training tools
- Established a network and relationship with KOL, associations, and medical experts
- Close co-operation with R&D at the head office of the Sysmex Corporation in Japan

07/2000 - 03/2001
Product Specialist EMEA
SYSMEX EUROPE GmbH

- Including deputy Product Manager EMEA responsibilities, application support within product
management and application specialists in central Europe for business partners, affiliates

08/1999 - 06/2000
Consultant for Mid-Tier Company Marketing Projects
ACS Ammon Consulting & Schulungen


07/1996 - 06/2000
Medical Technical Assistant (Lab Diagnostics Oncology / Immunology)
Institute for Immunology, University of Erlangen


04/1994 - 03/1998
Medical Technical Assistant (Lab Diagnostics, Clinical Chemistry)
Erlangen Regional Hospital


09/1991 - 10/1992
Medical Technical Assistant (Lab Diagnostics, Epilepsy)
Neurological Clinic, University of Erlangen


07/1988 - 08/1991
Medical Technical Assistant (Lab Diagnostics, Oncology, Hematology)
Children and Youth Clinic, University of Erlangen


Local Availability

Only available in these countries: Germany
Profileimage by Susanne Jaekel Freelancer (IVD In vitro diagnostics) Regulatory, Quality Management from Norderstedt Freelancer (IVD In vitro diagnostics) Regulatory, Quality Management
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