Regulatory Affairs Manager

About the job

Are you looking for a responsible position in Regulatory Affairs with an international focus? In this role, you will manage regulatory activities for the US market (FDA) as well as other global markets and accompany products throughout their entire lifecycle. You can expect a diverse range of tasks with a high degree of personal responsibility and close collaboration with various departments and a team that wants to achieve something together.

What you can achieve

US Market (FDA)

• Development and implementation of the regulatory strategy for the US market
• Independent planning, management, and submission of 510(k) dossiers as well as their lifecycle management
• Design and execution of FDA Q-Submissions (Pre-Submissions) to minimize risks and accelerate approvals
• Main contact person for communication with the FDA including management of inquiries, statements, and regulatory processes
• Assessment of regulatory impacts of product changes ("Significant Changes") including strategic decision-making
• Proactive monitoring and interpretation of new FDA requirements including integration of regulatory changes into existing processes and systems
• Ensuring sustainable compliance with FDA regulations throughout the entire product lifecycle including timely updates and fee management
• Responsibility for the creation, maintenance, and further development of FDA-compliant product documentation in close cooperation with internal interfaces and external partners
• Coordination of labeling, claims, and UDI requirements for the US market
• Support of US post-market activities including vigilance, evaluation of reportable events, and field actions in coordination with Quality Management
• Subject matter expert for regulatory issues related to USA/FDA topics with: advising departments and supporting development and approval projects 

International Responsibility (EU, MDSAP, other markets)

• Development and implementation of regulatory strategies and plans for new country approvals and market expansions (outside the USA) in coordination with the global/US strategy
• Identification, monitoring, and coordination of country approvals as well as product-specific regulatory requirements in collaboration with authorities, notified bodies, and external service providers 
• Creation and maintenance of approval documentation and maintenance of product files according to EU-MDR and other international requirements 
• Active participation in conformity assessment procedures as well as professional support in international approval/registration activities
• Ensuring compliance with regulatory requirements according to EUMDR, MDSAP, and other international regulations, as well as professional support during audits (e.g., MDR, MDSAP, EN ISO 13485) 

What distinguishes you

• Completed studies in a relevant field (e.g., medical technology, life sciences, regulatory affairs, or comparable)
• Several years of professional experience in the regulatory affairs environment of medical technology or a related industry
• In-depth knowledge of FDA regulations (especially 510(k) and Q-Submissions) is mandatory
• Good knowledge of EU MDR, MDSAP, and ISO 13485 (supportive for international registrations)
• Experience in preparing and submitting regulatory documentation for the US and international markets
• Entrepreneurial thinking and the ability to interpret regulatory requirements strategically
• Independent, structured, and solution-oriented working style
• Strong ability for cross-departmental collaboration
• Fluent oral and written language skills in German and English
• High initiative and decisiveness

What to expect from us

• An open "du" culture and a family-like atmosphere
• Comprehensive onboarding and an individually designed introduction program with insights into various departments
• Meaningful work that improves the lives of others
• At least 5 weeks of vacation plus compensatory days
• Flexible working hours and the possibility to work partly comfortably from home
• Support for professional development through targeted training and further education
• Coverage of daily sickness allowance premiums
• Free parking spaces as well as charging options for electric vehicles
• Free coffee, tea, fresh fruit, and 15 minutes of paid break time