Diabetes Care Regulatory Strategy Lead

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott is seeking a Regulatory Affairs Manager for onsite work in Alameda, Milpitas, or Austin to lead regulatory strategy and lifecycle management for Diabetes Care products. You will mentor staff, partner with R&D, quality and commercial teams, and steer FDA pathways and submissions to timely approvals.

The role requires a Bachelor's degree and 4+ years in a regulated industry, with strong communication and negotiation skills. Base pay reflects a wide range with comprehensive benefits.

Qualifications

• Bachelor's degree or equivalent experience.
• 4+ years in a regulated industry with regulatory exposure preferred.
• Excellent communication and negotiation skills.

Responsibilities

• Drive U.S. regulatory strategy for new products and lifecycle management.
• Lead and mentor a team of regulatory professionals.
• Partner with R&D, clinical, quality and commercial teams to influence development.
• Drive and provide guidance on FDA pathways and submissions (510(k), PMA, etc.).
• Negotiate with regulatory authorities to obtain timely approvals.
• Ensure compliance with regulatory standards and corporate policies.
• Identify regulatory risks and propose solutions with cross-functional teams.
• Develop and streamline regulatory policies, processes and SOPs.
• Stay ahead of evolving regulatory requirements and implement changes.
• Manage on-time completion of regulatory activities and milestones.
• Support post-approval manufacturing and design changes.

Skills

Regulatory strategy

Team leadership

FDA submissions

Cross-functional collaboration

Verbal and written communication

Education

Bachelor's Degree in related field

Job description

Abbott is seeking a Regulatory Affairs Manager for onsite work in Alameda, Milpitas, or Austin to lead regulatory strategy and lifecycle management for Diabetes Care products. You will mentor staff, partner with R&D, quality and commercial teams, and steer FDA pathways and submissions to timely approvals.

The role requires a Bachelor's degree and 4+ years in a regulated industry, with strong communication and negotiation skills. Base pay reflects a wide range with comprehensive benefits.