Senior QA Specialist – MDR & Regulatory Compliance

Abbott; Princeton (NJ); Presencial; USD 78.000 - 156.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage in HIP PPO plan

Excellent retirement savings plan

Tuition reimbursement and FreeU

Descripción de la vacante

Abbott Point of Care seeks a Senior Specialist Quality Assurance in Princeton, NJ. You will oversee daily compliance with domestic and international regulations, handling complaints and MDR submissions. You will file FDA, Health Canada, and global regulatory reports as needed, elevating issues for management decisions.

You will work with Medical Affairs, Technical Support, and Investigation teams to gather accurate data, ensuring timely reportability decisions and continuous process improvements.

Formación

• Associate degree required.
• 2-4 years of relevant engineering/technical experience.
• Advanced computer skills including statistics and reporting.
• Strong communication and teamwork skills.
• Ability to work in a diverse environment.

Responsabilidades

• Schedule day-to-day activities to ensure timely review of medical event files.
• Assess reportability and file reports in compliance with worldwide regulations.
• Collaborate with Medical Affairs, Technical Support, and Investigation teams to obtain necessary information.
• Make timely decisions and know when to elevate to management.
• Coordinate changing priorities.
• Use tools to monitor progress and results.
• Provide data and metrics to international offices and regulators.
• Comply with FDA regulations and company policies.
• Maintain positive communications with employees, distributors and partners.
• Perform verification of vigilance reports and metrics data.
• Manage RCML process by running monthly reports and reporting as needed.

Conocimientos

Advanced computer skills

Statistical/data analysis

Report writing

Strong communication

Teamwork

Organizational skills

Diversity environment

Educación

Associate degree

Bachelor’s degree (preferred)

Descripción del empleo

Abbott Point of Care seeks a Senior Specialist Quality Assurance in Princeton, NJ. You will oversee daily compliance with domestic and international regulations, handling complaints and MDR submissions. You will file FDA, Health Canada, and global regulatory reports as needed, elevating issues for management decisions.

You will work with Medical Affairs, Technical Support, and Investigation teams to gather accurate data, ensuring timely reportability decisions and continuous process improvements.