Role Description1. To work on global Regulatory Affairs projects supporting business needs in the medical device area including new product developments, roll-outs and maintenance projects. 2. To help ensuring compliance with ISO13485, ISO14971 and other harmonized standards 3. To help ensuring compliance with EU Medical Device Directive/EU Medical Device Regulation & other related regulatory requirements including relevant ISO standards
Responsibilities1. Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation 2. As part of the team support the process of CE marking of new and existing products 3. As part of the team ensure product notifications/certifications/registrations are correct and compliant with the relevant legislation. A. Maintain, review, approve and update of technical files compliance with the MDD 93/42/EEC and IVD 98/79/EC B. Approve Master Artwork and Master Texts from a regulatory perspective C. Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory D. Initiate corrections to Master Documents & Regulatory Affairs Procedures as required E. Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes 4. Analyze regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and provide regulatory intelligence 5. Carry out other related regulatory affairs duties as required
Requirements• ‘Give it a go’ and positive attitude being keen on creative and problem solving thinking whilst being thorough and focussed with the necessary attention to detail. • Ability to work on several projects in parallel in a flexible manner both autonomously and in a team environment. • Good communication skills. • Passion for regulatory affairs
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.