Regulatory Affairs Manager — Medical Devices (Onsite)

Abbott; Santa Clara (CA); Presencial; USD 114.000 - 228.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development

Free HIP PPO medical coverage next yr

High employer contribution retirement

Tuition reimbursement

FreeU education benefit

Descripción de la vacante

Abbott is seeking a Regulatory Affairs Manager for its Santa Clara, CA location in the Abbott Vascular Division. You will combine scientific, regulatory, and business insights to enable safe and compliant medical products, including combination products, from development through market release.

You will lead regulatory strategies, prepare submissions (FDA and international), mentor staff, and collaborate across cross-functional teams to ensure timely compliance with US and global requirements.

Formación

• Bachelor's Degree or equivalent; 4+ years in a regulated industry.
• Ability to communicate effectively with diverse audiences.
• Experience leading cross-functional teams in regulatory submissions.

Responsabilidades

• Develop regulatory policies, processes and SOPs; train staff.
• Evaluate regulatory risks of division policies and procedures.
• Provide regulatory input to product lifecycle planning and strategy.
• Prepare robust regulatory submissions (FDA and international).
• Lead cross-functional regulatory strategy and compliance across products.

Conocimientos

Verbal communication

Written communication

Cross-functional leadership

Regulatory awareness

Strategic thinking

Educación

Bachelor's Degree (related field)

4+ years in regulated industry

Descripción del empleo

Abbott is seeking a Regulatory Affairs Manager for its Santa Clara, CA location in the Abbott Vascular Division. You will combine scientific, regulatory, and business insights to enable safe and compliant medical products, including combination products, from development through market release.

You will lead regulatory strategies, prepare submissions (FDA and international), mentor staff, and collaborate across cross-functional teams to ensure timely compliance with US and global requirements.