Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

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Arbeitgeber: Carl Zeiss AG

Jobdatum: 27. November 2022

Einstiegsart: Professionals Jobs

Einsatzort: München; Bayern


Stellenbeschreibung - Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

connecticum Job 1586899

Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

Your Role:

 

As Clinical Affairs Manager (m/f/x) you will work in a team on the creation and implementation of the clinical strategy for the international approval of new and further developments of medical devices with focus on SaMD.

For this purpose you define, plan and implement necessary clinical projects and evaluate clinical data for product definition, regulatory and marketing purposes.

For the optimal design of medical device development you will work in close coordination with Regulatory Affairs, Development, Quality Management, Product Management and global Clinical Affairs Teams.

You can expect the following tasks:

 

  • Coordinate with your team colleagues to plan and prepare clinical assessments according to MDR, MEDDEV 2.7/1 revision 4

  • Support in the definition and implementation of clinical strategies for international approvals outside the EU (e.g. China, USA)

  • Independent planning and fulfillment of activities on medical devices in the area of Post Market Clinical Follow-Up and support in the area of Post Market Surveillance

  • Support of product management in the definition of intended use, clinical claims and release of marketing materials, taking into account the available clinical evidence

  • Planning and execution of clinical studies worldwide in compliance with applicable laws, regulations and Good Clinical Practice

  • Support of Investigator Initiated Trials

  • Support of the project manager of development projects in the coordination of interfaces of all clinical tasks assigned to the project with regard to content, execution, scheduling and technical documentation

  • Generate clinical evidence using bench tests, validations, etc.

  • Performing and evaluating literature searches

  • Creation of harmonized Standard Operation Procedures and Work Instructions after performing gap analyses taking into account regulatory requirements

 

 

Your profile:

 

  • a university degree in medicine, medical technology, ophthalmic optics/optometry or natural sciences

  • (alternatively state-approved optometrist or comparable training)

  • Ideally 3 years relevant professional experience in the field of clinical affairs or clinical research in the medical technology industry, ideally SaMD

  • Profound knowledge of the relevant regulatory requirements for clinical evaluations and clinical studies for medical devices, ideally SaMD

  • Practical experience in project management

  • Practical experience in medical writing

  • Global understanding of the requirements for the approval of medical products

  • Interest in digital software products and advanced technologies concepts such as Artificial Intelligence, Machine Learning, Cloudbased Products and more

  • Analytical skills and creativity as well as strong communication and organizational skills in an international environment

  • A high level of commitment and creative drive as well as strong communication skills and organizational talent in an international environment

  • the ability to communicate confidently in English, ideally also in German

 

Your ZEISS Recruiting Team:

Dogan Küncekli

Informationen zur Bewerbung
Stellenangebot:

Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

Jobkennzeichen:
Connecticum Job 1586899
Bereiche:
Ingenieurwissenschaften: Medizintechnik, Qualitätssicherung
Sonstige: Humanmedizin
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