Regulatory Affairs Specialist in Santa Clara

Regulatory Affairs Specialist
Abbott Laboratories
Santa Clara CA USA

Job Details

Updated on 2019-05-20

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.

     

JOB DESCRIPTION:

Summary:

As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level, participating in cross-functional teams. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

In this role, the regulatory affairs specialist will provide global regulatory support for Abbott Vascular's medical device products, which may include regulatory submissions, existing product maintenance and new product development.

Qualifications:

This position does not require previous regulatory experience, but it is strongly preferred. 2-3 years experience in a regulated industry (e.g., medical devices, pharmaceuticals) is required. Regulatory area is 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.

Additional Knowledge and Responsibilities:

Regulatory history, guidelines, policies, standards, practices, requirements and precedents. Regulatory agency structure, processes and key personnel. Principles and requirements of applicable product laws. Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs). Principles and requirements of promotion, advertising and labeling. Domestic and international regulatory guidelines, policies and regulations. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Write and edit technical document.s Negotiate internally. Pay strong attention to detail. Manage projects. Create project plans and timelines. Think analytically and critically. Organize and track complex information. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on the business. Apply business and regulatory ethical standards.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Santa Clara : Building B - SC Floor-2

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Regulatory Affairs Specialist
Abbott Laboratories
Santa Clara CA USA