Regulatory Affairs Specialist, Medical Devices

Abbott; Illinois; Sur place; USD 61 000 - 123 000; Plein temps

Résumé du poste

Abbott Laboratories in Abbott Park, IL, is seeking a Regulatory Affairs Specialist to support the Transfusion Medicine business. You will work as part of the regulatory functional product team and help ensure compliance for instrument hardware and software across US and international markets.

This role collaborates with Regulatory and cross-functional teams to prepare registrations, respond to inquiries, and monitor regulatory changes.

Qualifications

• Bachelor's degree in science or medically related field.
• 2–3 years in a regulated industry (medical devices or pharmaceuticals).
• Regulatory experience preferred; RAC and FDA submissions experience a plus.

Responsabilités

• Participate as regulatory team member for Transfusion Medicine regulatory team.
• Support regulatory activities for market entry and on-market support of instrument hardware and software.
• Collaborate with Regulatory and Core Functional teams to improve deliverables.
• Prepare documentation for registrations worldwide or oversee such preparation.
• Monitor regulatory changes and communicate timelines to the core functional product team.

Connaissances

Regulatory Affairs

Medical devices

FDA submissions

Formation

Bachelor's degree in science

Description du poste

Abbott Laboratories in Abbott Park, IL, is seeking a Regulatory Affairs Specialist to support the Transfusion Medicine business. You will work as part of the regulatory functional product team and help ensure compliance for instrument hardware and software across US and international markets.

This role collaborates with Regulatory and cross-functional teams to prepare registrations, respond to inquiries, and monitor regulatory changes.