Global Regulatory Affairs Lead – Medical Devices

Regulatory Toolkit; Santa Clara (CA); Sur place; USD 90 000 - 180 000; Plein temps

Avantages offerts par ce poste

HIP PPO medical plan

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Résumé du poste

Abbott seeks a Senior Regulatory Affairs Specialist (International) to support regulatory activities from its Santa Clara, CA site. You will oversee global filings, assist with SOPs, and coordinate submissions outside the US and EU, ensuring compliance and timely registrations across multiple markets.

Your role involves analyzing regulatory histories, collaborating across functions, and guiding product development with regulatory insight.

Qualifications

• Bachelors degree or equivalent in a related field.
• 3–4 years in a regulated industry; 2–3 years in regulatory preferred.
• Excellent verbal and written communication skills.
• Strong organizational skills and attention to detail.
• Experience with regulatory submissions (510(k), PMA) is a plus.

Responsabilités

• Manage and oversee global filings for sustaining changes and new product registrations.
• Assist in SOP development and regulatory input to lifecycle planning.
• Assess regulatory implications and communicate submission requirements.
• Prepare and submit regulatory documentation to authorities.
• Interact with regulatory authorities during development and review processes.
• Maintain licenses, registrations, listings, and patent information.

Connaissances

Regulatory knowledge

Communication skills

Organizational skills

Cross-functional collaboration

Data analysis

Formation

Bachelor's degree

Regulatory certification (RAC)

Description du poste

Abbott seeks a Senior Regulatory Affairs Specialist (International) to support regulatory activities from its Santa Clara, CA site. You will oversee global filings, assist with SOPs, and coordinate submissions outside the US and EU, ensuring compliance and timely registrations across multiple markets.

Your role involves analyzing regulatory histories, collaborating across functions, and guiding product development with regulatory insight.