Associate Director, Regulatory Affairs (on-site)

The Opportunity

This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have revolutionized the way roughly 7 million people worldwide manage their diabetes.

This is an exciting opportunity to shape and execute regulatory strategies across the total product life cycle, driving innovation in next-generation diabetes management and digital health technology solutions. The individual has department level influence with experience in leading and developing high-performing teams and is generally recognized as an expert resource both within Abbott and externally. The individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics.

This is an opportunity to make a meaningful impact on patient access and innovation, while elevating your visibility and leadership within a dynamic, mission-driven organization.

What You’ll Work On

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop and communicate a vision for the organizational unit assigned.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Write and edit technical documents.
• Recruit, develop and manage regulatory professionals.
• Evaluate performance of and assists in career development planning for subordinates.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Review and approve labeling to ensure compliance.
• Monitor emerging issues and identify solutions.
• Negotiate internally and externally with regulatory agencies.
• Identify need for new regulatory policies, processes and SOPs and approve them.
• Evaluate regulatory risks of corporate policies.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post-marketing approval requirements.
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
• Actively contribute to the development and functioning of the crisis/issue management program
• Analyze product-associated problems and develop proposals for solutions.
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.

Required 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 affairs, operations, or related area. Note: Higher education may compensate for years of experience.

Preferred Qualifications

• Bachelor's degree in computer science, math, engineering, or medical fields.
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Experience with Class III US and EU submissions and Software as a Medical Device (SaMD)
• Experience with FDA QSR and EU MDR and interfacing directly with regulatory authorities.
• 7-10 years’ experience in a regulated industry. Regulatory area is preferred but may consider software or systems research and development, or related area.
• Ability to work effectively on cross-functional teams.
• Must be able to juggle multiple and competing priorities.
• Strong written, verbal, presentation, and organizational skills.
• Has a sound knowledge of a variety of alternatives and their impact on the business.