Abbott Senior Specialist Regulatory Affairs in Princeton, New Jersey

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.

Abbott Point of Care is a global leader in providing critical medical diagnostic and informatics products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making as well as optimize resource utilization for our customers and the patients that they serve. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for respiratory, metabolic, coagulation, hematology, glucose, and cardiac function. By delivering lab-quality results in minutes, on just a few drops of blood, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.

Hi, my name is Susan. I lead the Regulatory team at Abbott Point of Care. I am looking to develop the next generation of Regulatory Professionals. We have new technology with new applications that will raise point of care testing to a new level. If you are a high energy individual that likes to be at the cutting edge of technology and regulatory science, join us. You will have the opportunity to interact with US and worldwide Health Authority Agencies. You will have up to the minute worldwide regulatory intelligence on the ever changing regulatory environment. Let’s navigate the global regulatory landscape to bring these much needed innovations to patients worldwide.

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.

Ability to execute highly complex or specialized projects.

Adapts precedent and may make significant departures from traditional approaches to develop solutions.

MAIN RESPONSIBILITIES

•As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

• Interacts with regulatory agency to expedite approval of pending registration.

• Serves as regulatory liaison throughout product lifecycle.

• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.

• Serves as regulatory representative to marketing, research teams and regulatory agencies.

• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Education

Associates Degree

Experience/Background

Minimum 7 years

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