Global Regulatory Operations Specialist – Med Tech

Regulatory Jobs; Alameda (CA); Sur place; USD 100 000 - 200 000; Plein temps

Avantages offerts par ce poste

Health coverage

Tuition reimbursement

FreeU education benefit

Retirement plan with employer contrib.

Diversity programs

Résumé du poste

Abbott is seeking a Principal International Regulatory Operations Specialist to work on-site in Alameda, CA. You will provide SME regulatory execution across global submissions, lead cross‑functional teams, and help shape regulatory strategies for diabetes care products.

Responsibilities include horizon scanning, lifecycle planning, and coordination with regional teams to maintain registrations. A strong background in medical devices/pharma regulations and excellent communication are essential.

Qualifications

• Bachelor’s Degree in Scientific discipline or equivalent.
• Experience regulatory submissions for pharmaceutical or medical devices.
• Familiarity with 21 CFR 820, ISO 13485, and related directives.

Responsabilités

• Participate in regulatory input for product and process changes.
• Coordinate regional registration strategies and submission maintenance.
• Lead cross‑functional working sessions; track actions and deadlines.
• Develop regional regulatory strategies and assess regulatory history.
• Support risk assessments, gap analyses, and closure plans.

Connaissances

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Regulatory compliance

Excel

PowerPoint

Veeva Vault

Communication skills

Formation

Bachelor’s degree in science

Outils

Veeva Vault

Excel

PowerPoint

Description du poste

Abbott is seeking a Principal International Regulatory Operations Specialist to work on-site in Alameda, CA. You will provide SME regulatory execution across global submissions, lead cross‑functional teams, and help shape regulatory strategies for diabetes care products.

Responsibilities include horizon scanning, lifecycle planning, and coordination with regional teams to maintain registrations. A strong background in medical devices/pharma regulations and excellent communication are essential.