Regulatory Affairs Manager — Medical Devices (Global)

Regulatory Jobs; Santa Clara (CA); Presencial; USD 114 000 - 228 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health coverage

Retirement plan

Tuition reimbursement

Education benefit

Resumo da oferta

Abbott is seeking a Regulatory Affairs Manager for an onsite role at the Santa Clara, CA location. You will blend scientific, regulatory, and business insights to enable products meeting regulatory requirements across US and international markets.

The role requires leading regulatory programs, guiding cross-functional teams, and mentoring staff to ensure timely regulatory submissions and compliance. Abbott offers extensive health, retirement, and education benefits.

Qualificações

• Bachelor's Degree in a related field or equivalent experience.
• 2-5 years in regulatory or related area; higher education may compensate.
• Experience with domestic and international regulatory guidelines and submissions.

Responsabilidades

• Develop regulatory policies, processes and SOPs and train staff.
• Provide regulatory input to product lifecycle planning and development teams.
• Prepare robust regulatory applications (FDA and international) for submissions.
• Develop multi-country regulatory strategy and update it as regulations change.
• Lead regulatory activities and ensure on-time submissions and approvals.

Conhecimentos

Regulatory affairs

Regulatory strategy

Cross-functional leadership

Communication

Project management

Formação académica

Bachelor's degree in related field

Master’s or PhD in technical area (preferred)

Descrição da oferta de emprego

Abbott is seeking a Regulatory Affairs Manager for an onsite role at the Santa Clara, CA location. You will blend scientific, regulatory, and business insights to enable products meeting regulatory requirements across US and international markets.

The role requires leading regulatory programs, guiding cross-functional teams, and mentoring staff to ensure timely regulatory submissions and compliance. Abbott offers extensive health, retirement, and education benefits.