RA-specialist (medical devices) Locatie Regio Eindhoven Functie omschrijving RA-specialist (medical devices) For one of our clients we are looking for a RA-specialist, preferably within medical devices. Within this position you will support the R&D project teams by providing the regulatory requirements in the early development phase. Therefore, in this position you will closely cooperate with different departments, among which clinical affairs and Marketing. Key activities within this position are:      Directly responsible for document packages for regulatory submissions (coordination and preparation) to the EU, Canada and the US. Providing guidance on global compliance Ensure quality of deliverables executed according to regulations Participation in external audits Providing guidance to project teams on risk assessments and assist in the preparation of regulatory strategy . Functie eisen RA-specialist (medical devices) For this position we are looking for a Regulatory Affairs professional with the following background:     BSc or MSc degree in a farmaceutical discipline At least 2 years of experience within medical devices regulations Excellent English verbal and written communication skills Experience within IVD is a plus Bedrijfsprofiel Leading research organisation. Bedrijfscultuur Innovative and progressive working environment with room for personal development. Arbeidsvoorwaarden RA-specialist (medical devices) Employment: Starting with a 12 month employment, possibly followed by a permanent job. Salary indication: €3500 to €5500 gross/month Working hours: Fulltime Area: Region of Eindhoven Contactpersoon Annelies Smout T:(020) 4069 750 E:[email protected] Website: www.labresource.nl