Regulatory Affairs Specialist - ASAPMichael Page • Geneva, CH
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Regulatory Affairs Specialist - ASAP
Michael Page • Geneva, CH
Vor 30+ Tagen
StellenbeschreibungContribute to the development and execution of product registration plans Identify and compile documentation for regulatory submissions Create submission dossiers and support external consultants / distributors Coordinate with internal teams to ensure timely and compliant registrations Manage product lifecycle changes and assess regulatory impact Define action plans for modifications, including validation testing Update registration files in line with evolving standards Provide regulatory guidance to internal and external stakeholders Support declaration of conformity and product presentation to authorities Collaborate with both product development and registration teams Participate in regulatory strategy during late design phases Ensure documentation complies with MDR and other relevant regulations Available immediately Experience in regulatory affairs within the medtech or medical device industry Strong understanding of MDR and technical documentation requirements Comfortable reading and interpreting complex technical files Curious and proactive about medical technologies Ability to work cross-functionally with development and registration teams Skilled in compiling and managing submission dossiers Excellent communication and coordination skills Detail-oriented with strong organizational abilities Capable of supporting both strategic and operational regulatory activities Fluent in English; French is a plus Team player with a collaborative mindset Opportunity to work on diverse and innovative medical technologies Dynamic and collaborative work environment Career development within a growing international company
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Regulatory Specialist • Geneva, CH
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