Associate Director, Regulatory Affairs – Medical Devices

Abbott; Westford (MA); Vor Ort; USD 129.000 - 259.000; Vollzeit

Benefits dieser Stelle

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefits

Employer recognition

Zusammenfassung

Abbott is seeking an Associate Director, Regulatory Affairs to lead strategy and submissions for medical device products from our Westford, MA location. The role focuses on software-enabled medical devices, cybersecurity, AI, and life-cycle regulatory support, including leading a team and interfacing with regulatory agencies.

You will guide development teams, ensure compliance with FDA and global regulations, and drive proactive regulatory planning across the product lifecycle.

Qualifikationen

• Bachelor’s Degree or equivalent required.
• 5–7 years in regulated industry (medical products, nutritionals).
• Regulatory experience preferred; other relevant areas may be considered.

Aufgaben

• Set strategy and direct submissions for regulatory approvals and interface with agencies.
• Provide regulatory guidance to product development teams.
• Lead regulatory strategy for on‑market and sustaining activities including post‑market activities.
• Manage and develop regulatory staff and maintain knowledge of regulations and industry trends.
• Ensure regulatory data supports registrations worldwide and coordinates with executive management.

Kenntnisse

Regulatory leadership

Regulatory strategy

Team development

Ausbildung

Bachelor’s degree

MS or MBA preferred

Jobbeschreibung

Abbott is seeking an Associate Director, Regulatory Affairs to lead strategy and submissions for medical device products from our Westford, MA location. The role focuses on software-enabled medical devices, cybersecurity, AI, and life-cycle regulatory support, including leading a team and interfacing with regulatory agencies.

You will guide development teams, ensure compliance with FDA and global regulations, and drive proactive regulatory planning across the product lifecycle.