Regulatory Affairs Specialist - ASAP

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.

Description

• 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

Profile

• 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

Job Offer

• Opportunity to work on diverse and innovative medical technologies
• Dynamic and collaborative work environment
• Career development within a growing international company