You are responsible for planning and managing clinical studies, investigator initiated studies (IITs) and prototype testing projects involving human subjects across the wide product portfolio ranging from breastfeeding to medical vacuum solutions. As part of the R&D department reporting to the Director of Medical  Research and Clinical  Affairs, you ensure that all studies are conducted in compliance with applicable regulatory requirements as well as within the defined time and budget. , Working with internal and external partners is essential for success in this role.

Join Medela and help us turn science into care!

This is what you can move

• Implement and successfully complete clinical study operation tasks associated with company sponsored studies and Investigator Initiated studies ensuring compliance with relevant regulations and standards
• Manage  and  facilitate  prototype  testing  projects  involving  human  subjects,  mainly  in  the  area  of breastfeeding, including obtaining necessary approvals, recruiting participants, ensuring adherence to ethical guidelines and regulatory requirements
• Establish and maintain relationships with KOLs
• Support the creation, evaluation, reconciliation  and  organization  of  the  management  release  of  the  annual  clinical  trial  /  case  series portfolio
• Evaluate and substantiate clinical claims related to Medela’s medical  devices based on scientific evidence and regulatory requirements.  Collaborate with cross-functional teams to gather necessary data and documentation
• Keep up to date with the latest scientific literature, clinical guidelines, and regulatory changes relevant to the products and clinical investigations
• Contribute to establishing scientific publications by developing and reviewing manuscripts/abstracts/posters in collaboration with internal and external stakeholders
• Be familiar with and provide support in the development and execution of CEPs, CERs, PMCF plans and reports.

What you bring along

• Master’s degree combined with a minimum of 3 years of experience in a  similar  clinical  affairs  role  within  the  medical  device  or pharmaceutical industry or at a CRO
• Knowledge of clinical research regulations (e.g.,  MDR,  FDA,  ISO) and guidelines (e.g.,  ICH-GCP) governing clinical research
• Demonstrated experience in conducting clinical studies, including protocol  development, study execution, data analysis, and reporting
• Good project management skills with the ability to prioritize tasks, meet  deadlines, and adapt to changing project requirements
• Exceptional communication and interpersonal skills to effectively collaborate with internal teams, external investigators, and KOLs
• Strong analytical and critical thinking abilities to assess and interpret scientific literature, clinical data, and regulatory requirements
• Fluent in English and German

What we offer you

• Medela Family: A culture characterized by inclusivity and respect that values and supports every member of our team. Together, we pursue one goal: improving the lives of mothers, babies and patients by translating science into care.
• Flexibility: If your role allows for it, you can work in a hybrid model with up to 3 days per week working from home.
• Growth Opportunities: a range of learning initiatives, both on and off the job.
• Competitive package: Benefits align with international benchmarks, including extended maternity/paternity leave, insurance, and additional vacation or bridge days.
• Balance: A variety of activities designed to promote health and well-being.

We focus on the personality and professional skills of our candidates. We reject any form of discrimination and look forward to receiving your application.

The hiring process of this position is supported by the responsible Talent Acquisition Manager Julia Winkler. In case of specific questions please contact us on +41 41 562 1077.

For this recruitment we will not consider any applications sent through by agencies.