Global Regulatory Affairs Director

Abbott (abbottcareers2 board); United States; On-site; USD 170,000 - 210,000; Full time

Job summary

Abbott in Alameda, CA seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies across the full product lifecycle for diabetes care and digital health solutions. This on-site role requires deep regulatory expertise and the ability to influence evolving regulations with external agencies.

You will mentor teams, drive submissions, negotiate with regulators, and advise executive management with strategic metrics to advance patient access and innovation.

Qualifications

• Bachelor's degree.
• 5-7 years' experience in a regulated industry (e.g., medical products).
• 5-7 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific a

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze regulatory outcomes with initial product concepts and recommend future actions.
• Provide technical leadership on complex issues to business units.
• Anticipate regulatory obstacles and develop solutions with regulatory teams.
• Lead and communicate a vision for the regulatory unit.
• Create project plans and timelines.
• Lead teams in developing data for regulatory submissions.
• Write and edit technical documents.
• Recruit, develop and manage regulatory professionals.
• Evaluate performance and career development of subordinates.
• Ensure compliance with regulatory requirements and avoid enforcement actions.
• Negotiate with regulatory authorities to secure submission approvals.
• Review and approve labeling for compliance.
• Monitor emerging issues and identify solutions.
• Identify need for new regulatory policies and SOPs and approve them.
• Evaluate regulatory risks of corporate policies.
• Maintain licenses, registrations, listings and patent information.
• Ensure post-marketing compliance for products.
• Develop and manage SOPs and systems for tracking product events.
• Contribute to crisis/issue management program.
• Analyze product-related problems and propose solutions.
• Oversee reporting of safety events to regulatory agencies.
• Provide regulatory input for recalls and recall communications.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree

Job description

Abbott in Alameda, CA seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies across the full product lifecycle for diabetes care and digital health solutions. This on-site role requires deep regulatory expertise and the ability to influence evolving regulations with external agencies.

You will mentor teams, drive submissions, negotiate with regulators, and advise executive management with strategic metrics to advance patient access and innovation.