Regulatory Complaints Specialist II - Medical Devices

Johnson & Johnson MedTech; Santa Clara (CA); Presencial; USD 75.000 - 120.750; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Vacation: 120 hours per year

Sick time: 40 hours per year

Holiday pay: 13 days per year

Parental Leave: 480 hours

Volunteer Leave: 32 hours per year

Descripción de la vacante

A leading medical technology company is seeking a Complaints Specialist II in Santa Clara, CA. The role requires ensuring compliance with regulatory standards for medical devices. Responsibilities include initiating complaints, collaborating with teams, and reporting regulatory metrics. Ideal candidates should have a degree alongside several years of relevant experience, with strong communication and data analysis skills. Competitive compensation and substantial benefits are offered.

Formación

• Experience with FDA/ISO audits is a plus.
• Ability to understand QMS procedures.
• Can work as a team member or independently.

Responsabilidades

• Ensure compliance with the Complaints System.
• Initiate complaints and gather required information.
• Collaborate with Safety on adverse events.

Conocimientos

Medical Device Complaint handling

Post Market Surveillance

Regulatory reporting

Data compilation and analysis

Excellent written and verbal communication

Strong interpersonal skills

Time management

Educación

Associate's degree with 4+ years of experience

Bachelor's degree with 2+ years of experience

Herramientas

MS Word

Excel

PowerPoint

Descripción del empleo

A leading medical technology company is seeking a Complaints Specialist II in Santa Clara, CA. The role requires ensuring compliance with regulatory standards for medical devices. Responsibilities include initiating complaints, collaborating with teams, and reporting regulatory metrics. Ideal candidates should have a degree alongside several years of relevant experience, with strong communication and data analysis skills. Competitive compensation and substantial benefits are offered.