Clinical Development Scientist

In this role, you have the opportunity to
Ensure that studies (clinical and non-clinical) for product approvals in Mother and Childcare Business unit are appropriately designed throughout the entire product creation and lifecycle to deliver evidence of value

YourResponsibilities
•   Providing support for the operation of clinical trials and product approvals in the USA, EU and ROW;
•   Obtaining approval to conduct clinical trials of investigational equipment;
•   Identifying and preparing clinical trial documentation (Protocol, Investigator Brochure, Consent Form, and Case Report Form) to obtain product approval and reimbursement classification for new products;
•   Developing documentation and obtain Competent Authority approval and Ethics approval for non-CE marked product in the European Union;
•   Developing IDE (Investigational Device Exemption), IRB (Institutional Review Board), 510(k) (Pre- Market Notification), and PMA (Pre-Market Approval) and Panel meeting documentation and receives approval to conduct clinical trial (IDE, IRB) or release device for sale (510(k), PMA);
•   Organizing, executing and submitting results of post marketing surveillance studies as mandated by FDA

Job families:
•   Lead clinical risk assessment throughout – from ideation through LCM
•   Development of evidence generation & dissemination strategies to support all innovation projects
•   Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per KM requirements (EU, China, etc)
•   Delivery of clinical programs, working in partnership with Clin Ops & BSDM
•   Lead dissemination of clinical evidence
•   Lead clinical scientific discussions with FDA, CAs, NBs, KOLs, Advisory Boards, etc

Requirements
•   Global Study Management, medical devices and/or life sciences or equivalent;
•   PhD degree or Master’s degree with 3-5 years of experience
•   Experience in clinical trials and development of clinical protocols and investigations;
•    Working knowledge of statistical analytics Working knowledge of FDA and ISO Regulations
•   Global product knowledge;
•   Problem solving skills for regulatory, quality and safety issues;
•   Fluency in English
•   Working from home is a possibility, but we are looking for someone who is available for at least 3 day in the office in Eindhoven (High Tech Campus)