Regulatory Affairs Director – Medical Devices & Software

Abbott (abbottcareers2 board); Westford (MA); On-site; USD 150,000 - 230,000; Full time

Job summary

Abbott in Westford, MA is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy across the product lifecycle for vascular and software-enabled medical devices.

You will direct submissions, guide product teams on regulatory requirements, oversee post-market activities, and mentor staff, ensuring compliance with global rules.

This on-site role emphasizes collaboration with senior management and external regulators to accelerate approvals and maintain registrations.

Responsibilities

• Set strategy and direct submissions for regulatory approvals.
• Provide guidance on regulatory requirements to product development project teams.
• Provide regulatory leadership for software-enabled medical devices, including cybersecurity considerations.
• Lead regulatory strategy for on-market and sustaining activities throughout the product lifecycle.
• Maintain knowledge of laws and enforcement decisions impacting QA, manufacturing and R&D.

Job description

Abbott in Westford, MA is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy across the product lifecycle for vascular and software-enabled medical devices.

You will direct submissions, guide product teams on regulatory requirements, oversee post-market activities, and mentor staff, ensuring compliance with global rules.

This on-site role emphasizes collaboration with senior management and external regulators to accelerate approvals and maintain registrations.