Regulatory Affairs Consultant

Law & Legal Advice

Skills

Description

Our client is a medical devices manufacturer, based in Netherlands with subsidiaries in Belgium and Luxembourg. Role description - Working closely with the product development and engineering team in order to ensure regulatory compliance - Participating in the early phase stage of the development of new medical devices - Ensuring regulatory aspects from early phase design, to design to manufacturing - Making sure that the Design History files and validations are in accordance with the applicable standards - Executing submissions for approvals in the EU and with the FDA Responsibilities - Maintain registrations and submitting new registrations (FDA / MDD) - Coordinate, implement and monitor Regulatory Activities - Maintain and update technical files - Approve all relevant documents, tests, validations in order to meet project requirements Requirements - 5-10 years of relevant experience preferably a technical background - Expertise in the Medical Devices Industry (preferably (early phase development) - Good knowledge and experience with 510(k) and CE submissions - Good understanding and knowledge of FDA regulations, ISO 13485, MDD 93 / 42 Location: Belgium, Netherlands, Luxembourg (readiness to travel) Salary: 650€/day (negotiable) Contract: Minimum of 12 months