Senior EU IVDR/MDR Regulatory Lead - Remote

C2N Diagnostics, LLC; United States; A distancia; USD 95.000 - 115.000; Jornada completa

Descripción de la vacante

C2N Diagnostics, a St. Louis-based biotech company, seeks a Sr International Regulatory Affairs Specialist to lead EU IVDR/MDR regulatory activities for its diagnostics and software offerings.

You will develop strategies, manage international submissions, and coordinate with notified bodies and authorized representatives while guiding lifecycle regulatory decisions. Remote position reporting to the Director of Regulatory Affairs, with up to 15% travel.

Formación

• Bachelor’s degree in life sciences, biomedical engineering, or related field.
• Minimum five years in medical device or IVD regulatory affairs with EU/international submissions.
• Strong expertise in EU IVDR and MDR and lifecycle management.
• Experience interacting with notified bodies and EU authorized representatives.
• Proven ability to prepare technical documentation and manage submissions.
• Experience registering products in multiple international markets.
• Knowledge of ISO 13485, ISO 14971, post-market surveillance, and UDI.
• Excellent technical writing, project management, and cross-functional communication.

Responsabilidades

• Develop and execute EU/international regulatory strategies.
• Prepare, review, and maintain technical documentation and submissions.
• Serve as primary regulatory contact with notified bodies and authorized representatives.
• Collaborate with R&D, QA, Clinical, IT, and Commercial teams to align with regulatory requirements.
• Assess changes to determine impact on certifications and registrations.
• Coordinate EU declarations of conformity, UDI, and regulatory responsibilities.
• Support post-market surveillance and vigilance activities.
• Support notified body audits and regulatory inspections.
• Monitor regulatory developments and maintain submission schedules.
• Support U.S. regulatory activities as assigned.

Conocimientos

Regulatory strategy

Technical writing

Project management

Cross-functional collaboration

Regulatory submissions

Stakeholder communication

Risk management

Educación

Bachelor’s degree in life sciences or related field

Advanced degree in relevant field

Regulatory Affairs Certification (RAC)

Descripción del empleo

C2N Diagnostics, a St. Louis-based biotech company, seeks a Sr International Regulatory Affairs Specialist to lead EU IVDR/MDR regulatory activities for its diagnostics and software offerings.

You will develop strategies, manage international submissions, and coordinate with notified bodies and authorized representatives while guiding lifecycle regulatory decisions. Remote position reporting to the Director of Regulatory Affairs, with up to 15% travel.