Regulatory Affairs Manager Heart Failure (on-site)

Regulatory Affairs Manager

We are seeking a Regulatory Affairs Manager to join Abbott's Heart Failure Division on-site in Pleasanton, CA.

As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department / group / site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

Regulatory Knowledge / Skills :

• Anticipate regulatory obstacles and emerging issues.
• Lead functional groups to complete a regulatory submission.
• Regulatory history, guidelines, policies, standards, practices, requirements and precedents
• Regulatory agency structure, processes and key personnel
• Principles and requirements of applicable product laws
• Principles and requirements of promotion, advertising and labeling
• Interpret and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities.
• Domestic and international regulatory guidelines, policies and regulations
• Ethical guidelines of the regulatory profession, clinical research and regulatory process

Communication :

Cognitive Skills :

Leadership :

Required Qualifications :

Preferred Qualifications :

The base pay for this position is $112,000.00 $224,000.00. In specific locations, the pay range may vary from the range posted.