Associate Director, Regulatory Affairs - Diabetes Care (on-site)

Abbott (abbottcareers2 board); United States; Sur place; USD 170 000 - 210 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

Formation

Bachelor's degree

Description du poste

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.


• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.


• An excellent retirement savings plan with high employer contribution


• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.


• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.


• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This Associate Director, Regulatory Affairs will work on-site at 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 a