This Job Vacancy has Expired!

Clinical Development Scientist

Posted on Jan 24, 2020 by Randstad Multilingual Recruitment Banen

Eindhoven, Netherlands
Health Care
Immediate Start
Annual Salary
Full-Time

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)

Reference: 832067776

Set up alerts to get notified of new vacancies.