Clinical Affairs Manager

vor 4 Wochen

München, Deutschland ZEISS Gruppe Vollzeit

Your role

  • Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product
  • Responsibility for budget and time planning for the entire clinical strategy and for compliance with this, taking into account economic aspects and project risks as well as defining minimization measures
  • Independently plan, generate and maintain clinical documentation for regulatory purposes (e.g. Clinical Evaluation Plan and Report, clinical content for regulatory submissions), including continuous gap analysis and conclusion on sufficiency of clinical evidence, adapt clinical strategy when necessary
  • Planning and execution of CA tasks of post-market surveillance incl. database analysis and literature search, regular update of clinical assessments
  • If necessary, selection and coordination of external service providers for the aforementioned activities Create and/or review manuscript for scientific publications Review and approval of product specific marketing materials and publications.
  • Support clinical/regulatory affairs teams worldwide in product registrations Report on project progress,
  • Act as an internal consultant/ subject-matter expert adaptation and improvement of Clinical Affairs processes.

Your profile

  • Education: Minimum four-year college degree in optometry, medicine, medical technology/engineering, or natural sciences.
  • At least 5 years of experience in Clinical Affairs/Clinical evaluation in the medical device industry or with contract research organizations.
  • Good knowledge of relevant regulatory requirements for clinical trials for medical devices (ICH-GCP, ISO 14155)
  • In-depth knowledge of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines) Other knowledge
  • Good knowledge in biostatistics, data interpretation, and critical reading of publications
  • Good knowledge of regulatory requirements for CE, FDA, NMPA, Health Canada, etc.
  • Demonstrated qualities in project management and medical writing
  • Strong analytical skills coupled with creativity and intuition
  • Commitment and creative drive as well as strong communication and organizational skills in an international environment
  • Very good oral and written communication in English
  • Willingness to travel worldwide

Your ZEISS Recruiting Team:
Celine Karbach

  • Clinical & Medical Affairs Manager

    vor 4 Wochen

    München, Deutschland Rhythm Pharmaceuticals Inc. Vollzeit

    Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. Rhythm is a global,...

  • Clinical Affairs Manager

    vor 1 Woche

    München, Deutschland ZEISS Gruppe Vollzeit

    Your role Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product Responsibility for budget and time planning for the...

  • Clinical Affairs Manager

    vor 1 Woche

    München, Deutschland ZEISS Gruppe Vollzeit

    Your role Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product Responsibility for budget and time planning for the...

  • Clinical Affairs Manager

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, Deutschland ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Clinical Affairs Manager

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, Deutschland ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Clinical Affairs Manager

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, DE ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Clinical Affairs Manager

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, DE ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Global Medical Clinical Development Director

    vor 2 Monaten

    München, Deutschland Archer Hires Vollzeit

    Medical Director Medical Affairs Oncology / Hematology Full-time Transition from medical practice to BioPharma Industry Clinical Physician Real work/life balance. Excellent compensation. Outstanding incentive/bonus programs. Medical Affairs Medical Director Oncology / Hematology The Medical Affairs Medical Director (MD) provides cross-functional leadership...

  • Director - Medical Affairs

    vor 2 Monaten

    München, Deutschland Integrated Resources Inc. Vollzeit

    A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide...

  • (Senior) Manager Medical Affairs

    vor 2 Wochen

    München, Deutschland Otsuka Novel Products GmbH Vollzeit

    Otsuka Novel Products GmbH (ONPG) is the global headquarter for a special pharmaceutical business within the Otsuka group. With an international network of 168 subsidiaries and 34,400 employees in 32 countries and regions across Europe, Asia-pacific, America and the Middle East, Otsuka researches, develops, manufactures and markets innovative and original...

  • (Senior) Manager Medical Affairs

    vor 2 Wochen

    München, München (Kreis), Deutschland Otsuka Novel Products GmbH Vollzeit

    Otsuka Novel Products GmbH (ONPG) is the global headquarter for a special pharmaceutical business within the Otsuka group. With an international network of 168 subsidiaries and 34,400 employees in 32 countries and regions across Europe, Asia-pacific, America and the Middle East, Otsuka researches, develops, manufactures and markets innovative and original...

  • Project Manager Clinical Operations

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, Deutschland ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Project Manager Clinical Operations

    vor 2 Wochen

    Jena # Berlin # München # Oberkochen, DE ZEISS Vollzeit

    Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of...

  • Senior Manager, Clinical Scientist

    vor 1 Woche

    München, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading...

  • Regulatory Affairs Associate Director

    vor 2 Monaten

    München, Deutschland Katalyst Healthcares & Life Sciences Vollzeit

    Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and...

  • Medical Director, Medical Affairs

    vor 3 Wochen

    München, Deutschland Rhythm Pharmaceuticals, Inc Vollzeit

    Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We...

  • (Senior) Clinical Study Manager

    vor 2 Wochen

    München, Deutschland Arthrex GmbH Vollzeit

    Wir gehören zu den weltweit führenden Unternehmen im Bereich Orthopädie, Arthroskopie, Sportmedizin und Orthobiologie. Getreu unserer Mission Helping Surgeons Treat Their Patients Better entwickeln wir seit 40 Jahren innovative Produkte und Operationsverfahren. Arthrex wurde 1981 in München gegründet - heute befindet sich unser Hauptsitz in Naples...

  • (Senior) Clinical Study Manager

    vor 1 Woche

    München, Deutschland Arthrex GmbH Vollzeit

    Wir gehören zu den weltweit führenden Unternehmen im Bereich Orthopädie, Arthroskopie, Sportmedizin und Orthobiologie. Getreu unserer Mission Helping Surgeons Treat Their Patients Better entwickeln wir seit 40 Jahren innovative Produkte und Operationsverfahren. Arthrex wurde 1981 in München gegründet - heute befindet sich unser Hauptsitz in Naples...

  • Regulatory Affairs Manager

    vor 2 Wochen

    München, Deutschland 3C - Career Consulting Company GmbH Vollzeit

    Für Beratung, die passende Arbeitgeber und Kandidaten zusammenführt. Und für ein Unternehmen, das sich seit 21 Jahren auf eine Aufgabe konzentriert: Executive Search für höchste Ansprüche. Unser Mandant entwickelt, produziert und vertreibt komplexe Medizinprodukte. Im Zuge des starken Wachstums des Unternehmens suchen wir zum nächstmöglichen...

  • Regulatory Affairs Manager

    vor 1 Woche

    München, Deutschland 3C - Career Consulting Company GmbH Vollzeit

    Für Beratung, die passende Arbeitgeber und Kandidaten zusammenführt. Und für ein Unternehmen, das sich seit 21 Jahren auf eine Aufgabe konzentriert: Executive Search für höchste Ansprüche. Unser Mandant entwickelt, produziert und vertreibt komplexe Medizinprodukte. Im Zuge des starken Wachstums des Unternehmens suchen wir zum nächstmöglichen...