#LI-medmix Regulatory Affairs Specialist - Full Time - Haag, Switzerland At medmix, our team is focused on a single mission, to provide innovative solutions that help millions of people live healthier and more confident lives. Join us to expand your career opportunities in a high growth business, where your unique skills are valued. Join our team in Haag and help shape our future Regulatory Affairs agenda. In this role you will be accountable for: * Compliance with regulatory, legal and normative requirements for SMS * Review and cooperation in the preparation of the technical documentation * Support the UDI implementation * Ensuring product approval in accordance with country-specific regulations * Observation and management of standards and directives, information on changes * Participation in system maintenance of ISO 13485 * Assisting in the implementation of the requirements of authorities, directives, customers and standards * Technical clarification and assessment of customer and authority requirements * Preparation and maintenance of system and technical documentation * Implementation of worldwide product approvals * Preparation and implementation of specialist employee training (GMP, hygiene, standards, etc.). * Duty to report to superiors in case of violation of legal compliance in medical devices issues * Support of requests from Industry segment- REACH/SVHC, RoHS and other directives and regulations To succeed in this role, you will need: * Technical or scientific degree (e.g. engineering, biology, chemistry) or equivalent profound work experience * 5 years of professional experience in research and development or quality management * 5 years of regulatory affairs experience for medical devices in the EU and / or international markets * Well-founded knowledge of MDR, GMP, ISO 13485, ISO 14971 and ISO 10993 * Pronounced evaluation and decision-making skills * Analytical capability as required in reviewing, assessing and interpreting the relevant requirements * Proactive personality with hands-on-mentality, strong communication skills and decisiveness * German and English on a business fluent level Your benefits: * An innovative, vibrant and agile culture * A dynamic business on a growth trajectory * Excellent social benefits * Opportunity to work remotely Do you have a question about the role? Reach out to Jürgen Schluderbacher at email@example.com Please use our Online-Tool to apply for this position. We are looking forward to hearing from you!