We are looking for a
Head of Clinical & Medical Affairs (M/F/X)
As an innovative and internationally oriented manufacturer of premium intraocular implants, we develop, produce and distribute medical devices in order to provide the human eye the best possible vision.
In order to strengthen our Clinical and Medical Affairs Department at the Erlangen site (Bavaria), we are looking in fulltime for a Head of Clinical & Medical Affairs (M/F/X)
MAIN RESPONSIBILITIES
- Responsibility for the Clinical & Medical Affairs department, employee
management and development - Definition/planning of clinical studies after the market launch nationally &
internationally - Preparation of study contracts
- Ensuring close communication and support for the study centers for an
adequate study management - Analysis, evaluation and preparation of relevant clinical data / study results
- Networking and collaboration with clinical study centers and KOLs
- Preparation, review and approval of publications, congress presentations and
marketing material - Participation in national & international exhibitions
- Organization and implementation of wetlabs
- Supporting market access procedures with the relevant bodies/authorities
nationally & internationally - Responsibility for budget and time planning for the entire clinical strategy
and its compliance, taking into account economic aspects and risks - Development, implementation and maintenance of Standard Operation
Procedures (SOP) for clinical trials and clinical evaluation - Independent planning, preparation and maintenance of clinical
documentation for regulatory purposes (e.g. Clinical Evaluation Plan and
Report, clinical content for marketing authorization applications) - Supporting the clinical/regulatory affairs team worldwide with product
registrations - Planning, control and responsibility of the department budget
- Improvement & further development of clinical & medical affairs processes
YOUR PROFILE
- Successfully completed studies in the field of medicine or natural sciences
(doctorate desirable) - At least 10 years of relevant professional experience in the field of Clinical &
Medical Affairs, Clinical Research in the medical technology industry - Experience in conducting clinical investigations of implantable medical
devices according to ISO 14155 - Experience with regulatory requirements for clinical trials in Europe, China,
USA and other countries - First experience in the management of employees
- Experience in the field of ophthalmology desirable, especially with
intraocular lenses - Strong communication and organizational skills in an international
environment - Convincing demeanor, even in front of larger groups
- Very good command of written and spoken English and German
OUR OFFER
- Varied and responsible activities in an innovative and future-oriented
company - Department management
- Exchange at eye level
- Collegial support culture
- Short decision-making processes due to a flat hierarchy
- Family friendliness
- 30 days vacation per year
Online-Form
Apply now
Please send your application, stating the earliest possible date of entry and your salary expectations to bewerbung@humanoptics.com
Kontakt
HumanOptics Holding AG
Personalabteilung, Herr Saß
Spardorfer Str. 150
91054 Erlangen
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