Senior Regulatory Affairs Specialist – MedTech Devices

Biopharma Careers; Warsaw (IN); Presencial; USD 90.000 - 125.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Warsaw, IN, USA seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for DePuy Orthopaedics devices. The role focuses on preparing documents for IDE, 510(k), PMA and global registrations, ensuring compliance with FDA, EU MDR, and ISO standards.

You will collaborate with cross-functional teams, review labeling and product claims, and support post-market activities and audits.

Formación

• Requires 2+ years in regulatory affairs or medical devices.
• Knowledge of FDA and EU MDR regulations a plus.
• Excellent written and oral communication skills; detail oriented.

Responsabilidades

• Prepares regulatory documentation for IDE, 510(k), PMA and Technical Documentation for regulatory submissions.
• Supports global registration activities (Japan, China, Australia, NZ) as required.
• Reviews and approves labeling, product support information, and promotional content for compliance.
• Keeps current knowledge of regulatory standards (FDA QSR, ISO 13485, MDR) and prepares for audits.
• Performs other duties as assigned.

Conocimientos

Regulatory affairs

Medical devices

FDA/EU MDR knowledge

Communication skills

Attention to detail

Educación

BA/BS Degree

Descripción del empleo

Johnson & Johnson in Warsaw, IN, USA seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for DePuy Orthopaedics devices. The role focuses on preparing documents for IDE, 510(k), PMA and global registrations, ensuring compliance with FDA, EU MDR, and ISO standards.

You will collaborate with cross-functional teams, review labeling and product claims, and support post-market activities and audits.