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.
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
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 firstname.lastname@example.org