Robotic Medical Devices Regulatory Lead (Remote)

Johnson & Johnson MedTech; United States; A distancia; USD 125.000 - 201.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote options

Travel up to 10%

Descripción de la vacante

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics, with remote options considered for the right candidate.

You will lead regulatory strategy for US and international submissions, collaborate with engineering and clinical teams, and prepare FDA submissions.

The role may require up to 10% travel and involves interactions with health authorities to enable timely market access for software-enabled robotic devices.

Formación

• Bachelor’s degree required; Advanced degree preferred.
• 6+ years of regulatory affairs in medical devices including software-enabled systems.
• Proven track record of securing regulatory approvals (e.g., 510(k), IDEs, De Novo).
• Excellent cross-functional communicator; able to influence within regulatory team and across functions.
• Independent strategic thinker; synthesize regulatory information to drive business priorities.
• Willingness to travel up to 10%.

Responsabilidades

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
• Act as regulatory SME across cross-functional partners with software-enabled electromechanical devices; review docs and provide regulatory feedback.
• Prepare and submit regulatory information for US market access, including FDA submissions and meetings.
• Manage sustaining activities: change assessments, registrations, renewals.
• Support global health authorities’ submissions and regulatory guidance compliance.

Conocimientos

Regulatory strategy

FDA submissions

Cross-functional collaboration

Software-enabled devices

Regulatory compliance

Project leadership

Risk management

Regulatory intelligence

Educación

Bachelor’s degree

Advanced degree

Descripción del empleo

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics, with remote options considered for the right candidate.

You will lead regulatory strategy for US and international submissions, collaborate with engineering and clinical teams, and prepare FDA submissions.

The role may require up to 10% travel and involves interactions with health authorities to enable timely market access for software-enabled robotic devices.