Preparation and maintenance of clinical evaluation reports and plans, literature search, PMCF plan reports and clinical safety management documents; Integrating quality and regulatory changes into clinical documentation;...Junior Clinical Scientific Manager (m/w/d)
Jr. Clinical Scientific Manager
Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.
Location: Jena or Bonn area
The Jr. Clinical Scientific Manager develops and maintains clinical evidence documentation and facilitates post market activities hereby supporting our products with regard to safety and clinical performance as well as product claims.
Your work will focus on
- Preparation and maintenance of clinical evaluation reports and plans, literature search, PMCF plan reports and clinical safety management documents.
- Integrating quality and regulatory changes into clinical documentation.
- Communication with Health Authorities and Notified Body regarding clinical safety and performance.
- Ensuring that clinical evidence requirements and the CERs comply with global medical device guidance and regulations.
- Developing and implementing clinical trial plans with CRM and CPM.
- Supporting development teams and product marketing campaigns.
- Supporting the Clinical team with technical expertise.
- Researching, collecting, presenting and offering expert opinion on scientific, medical and regulatory information.
- Managing the integrity and accuracy of scientific, medical and regulatory data.
- Assisting in audits.
- Developing good relationships with opinion leaders
- Contributing to the Occlutech QM system
We are looking for a candidate, who
- Has a Master’s Degree within a scientific field and preferably a PhD.
- Has experience within academia. Preparation of scientific articles is an advantage..
- Has knowledge of medical device regulations (including MDR, ISO, MEDDEV 2.7/1 rev. 4 would be a plus).
- Is a ream player with proven track record of working in a dynamic, internatinal environment.
- Has strong analytical and problemsolving skills and excellent interpersonal and communicational skills
- Has experience in using clinical trial management systems.
- Has knowledge of computer applications for the execution of daily project operations.
- Is experienced in presenting, data analysis and statistics.
- Is open to travel when needed.
- Has excellent knowledge of English and excellent communication skills.
Are you interested?
We look forward to receiving your application (cover letter, CV, including qualifications and references - all documents in one pdf file), your salary expectation and the earliest possible date for start of work to [email protected]. Only applications in English will be evaluated.
Occlutech GmbH Winzerlaer Str. 2 07745 Jena www.occlutech-jena.de www.occlutech.com
Occlutech GmbH Jena Winzerlaer Straße 2, 07745 Jena, Germany Tel +49 3641 508 324 [email protected], www.occlutech.com
© Occlutech 2018. All rights reserved. Occlutech is a registered trademark.
