AbbVie

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Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

Added

1 hour ago

Location

🌍 Worldwide

Type

Full time

Salary

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Related skills

regulatory affairs digital health regulatory submissions fda medical device

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📋 Description

Develop and implement US/Canada regulatory strategy for on-market or development products.
Align with GRPT; ensure strategies are executed and updated.
Gather data to support filings and regulatory inquiries.
Lead lifecycle activities: changes, post-approval, and regulatory responses.
Interface with FDA and coordinate meetings/briefing packages.
Advise internal teams on Regulatory/FDA issues across org.

🎯 Requirements

Advanced degree (PharmD/PhD/MS) or regulatory certification.
5+ years regulatory/R&D or related experience.
Experience in medical device space.
Experience with digital health/software.
Proven ability to implement affiliate regulatory strategies (US/Canada).
Experience in complex, matrix environments; interfacing with regulators.

🎁 Benefits

Comprehensive benefits package including PTO and insurance.
401(k) for eligible employees.
Participation in long-term incentive programs.

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