Regulatory Affairs Specialist

vor 3 Wochen

Genf, Schweiz Michael Page International (Switzerland) SA Vollzeit

Responsibilities - Play a key role in bringing innovative medical technologies to market - Collaborate with expert teams across product development and regulatory strategy - Contribute 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 About Our Client Our client is a leading player in the medtech industry, known for its collaborative culture and commitment to innovation. The company operates across multiple product lines and markets. The Successful Applicant - 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 Whats on Offer - Opportunity to work on diverse and innovative medical technologies - Dynamic and collaborative work environment - Career development within a growing international company #J-18808-Ljbffr

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