Abbott Director, Regulatory Operations in Sylmar, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

POSITION OBJECTIVE:

The function of a Director Regulatory Operations is to combine knowledge of scientific, regulatory and business processes to enable products that are developed, manufactured or distributed to meet required legislation. The successful individual will model and enhance a diverse and inclusive culture, as well as develop and supervise associates. The individual may have division level influence and will be considered a key opinion leader and resource at Abbott. The individual will plan, direct, coordinate and control the regulatory operations activities related to products worldwide. The individual may direct the development of strategy and organizational structure, optimizing processes and procedures to facilitate global registration and maintenance of product portfolio. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.

CORE JOB RESPONSIBILITIES:

  • Excellent communication and influencing skills

  • History of building strong, positive teams and ability to supervise staff across multiple sites

  • Analytical problem-solving skills

  • Develop and/or identify new work processes with broad applicability throughout the company

  • Direct investigations into problems impacting work processes and personnel

  • Manage projects and create project plans and timelines · juggle multiple and competing priorities

  • Has broad knowledge of various technical alternatives and potential impact on the business

  • Strong attention to detail

  • Organize and track complex information

  • Exercise good and ethical judgment within policy and regulations

  • Possess ability to define regulatory strategy.

POSITION ACCOUNTABILITY / SCOPE:

  • Key Process and Procedure Ownership

  • Establish & maintain procedures/Quality System

  • Business System/Process Ownership and associated metrics

  • Emerging Issues & Regulations facilitating global submission and approval

  • Division Corrective & Preventive Action

  • RA Education, onboarding, fundamentals

  • Authorization of Product Release (Process, Procedure and Training)

  • Product Labeling content requirements, facilitation of label implementation

EDUCATION/Certifications:

  • Bachelor's degree (or equivalent); Degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.

  • M.S. in a technical area or M.B.A. is preferred.

  • 10+ years’ experience in a regulated industry (e.g., medical products, nutritionals). 10+ years of experience in regulatory preferred but will consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

  • Six Sigma Certification preferred

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com