Global Post-Market Quality Specialist - Field Actions

Regulatory Jobs; San Diego (CA); Presencial; USD 130.000 - 207.000; Jornada completa

Descripción de la vacante

BD is seeking a Staff Specialist, Post Market Quality (PMQ) to serve as a global SME supporting post-market quality activities across the MMS portfolio. The role partners with the Senior Manager, PMQ to drive field actions, surveillance, risk management, and regulatory compliance.

The ideal candidate will have strong expertise in medical device quality systems and regulatory requirements, with the ability to influence decisions and align global stakeholders across Quality, Regulatory Affairs,

Formación

• Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or related technical field.
• Minimum 5 years of experience in Quality, Regulatory Affairs, Post Market Quality, Product Quality, or related functions within a regulated industry.
• Experience supporting post-market quality activities, quality investigations, risk management, or field actions.
• Strong analytical, problem-solving, and decision-making skills.
• Demonstrated ability to influence cross-functional stakeholders and drive organizational alignment.

Responsabilidades

• Lead and support the execution of global field actions, including recalls, corrections, removals, advisory notices, and other post-market actions.
• Develop and maintain field action documentation, rationale packages, health hazard evaluations, effectiveness strategies, and closure documentation.
• Partner with regional quality and regulatory teams to support consistent field action implementation across NA, EMEA, LATAM, and Greater Asia.
• Monitor field action progress, effectiveness, reconciliations, and closure activities to ensure compliance.
• Support regulatory submissions and notifications including FDA 806 reporting and global field action reporting requirements.

Conocimientos

Quality systems

Regulatory compliance

Risk management

Cross-functional influence

Educación

Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs

Descripción del empleo

BD is seeking a Staff Specialist, Post Market Quality (PMQ) to serve as a global SME supporting post-market quality activities across the MMS portfolio. The role partners with the Senior Manager, PMQ to drive field actions, surveillance, risk management, and regulatory compliance.

The ideal candidate will have strong expertise in medical device quality systems and regulatory requirements, with the ability to influence decisions and align global stakeholders across Quality, Regulatory Affairs,