Senior Regulatory Affairs Leader, Digital Health & SaMD

Thornton Tomasetti; California; Sur place; USD 131 000 - 261 000; Plein temps

Avantages offerts par ce poste

Health benefits

Retirement plan

Tuition reimbursement

Résumé du poste

Abbott is seeking a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will guide regulatory strategy, lead global submissions for SaMD, and interact with health authorities to enable market access.

You will collaborate with cross-functional teams on product lifecycle, labeling changes, and post-market activities while ensuring QMS and ISO compliance across regions.

Qualifications

• Bachelor’s degree or higher in a scientific or engineering field.
• Experience with US FDA device regulations and international pathways.
• Proven ability to author PMA and/or IDE submissions and regulatory filings.

Responsabilités

• Lead global regulatory submissions and agency interactions for SaMD.
• Develop regulatory strategies across product lifecycle and market access.
• Collaborate with cross-functional teams on labeling, post-market activities and changes.
• Mentor regulatory staff and ensure compliance with QMS and ISO standards.

Connaissances

Regulatory affairs

Global submissions

PMA/510(k)

EU MDR/CE

SaMD knowledge

Regulatory strategy

Cross-functional collaboration

Formation

Bachelor's degree in science or engineering

Master’s degree or RAC training (preferred)

Description du poste

Abbott is seeking a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will guide regulatory strategy, lead global submissions for SaMD, and interact with health authorities to enable market access.

You will collaborate with cross-functional teams on product lifecycle, labeling changes, and post-market activities while ensuring QMS and ISO compliance across regions.