Description

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 opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.

  • Participate in 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

  • 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.

  • Education: Minimum four-year college degree in optometry, medicine, medical technology/engineering, or natural sciences. Work Experience

  • At least 3 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

  • Knowledge in biostatistics, data interpretation, and critical reading of publications

  • 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 occasionally travel worldwide