Job Details

Senior-Specialist-Regulatory-Affairs

Company name
Abbott

Location
Princeton, NJ

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Profile

The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we’ve stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.

Position Summary

As an individual contributor, the Senior Regulatory Affairs Specialist will work with cross functional teams providing support to manufacturing and operations to ensure efficient and compliant business processes and environment. The primary focus will be on-market product design and manufacturing change as it relates to regulatory impact.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Communicate changes to the cross functional teams as well as provide regulatory requirement feedback to all parties.

Assist in identifying and obtaining necessary data to ensure it is effectively presented for the registration of products worldwide.

May prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Will sit on project teams/change review boards representing Regulatory.

Education and Qualifications

Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Note: Higher education may compensate for years of experience.

Experience of working with FDA regulations and working knowledge of regulatory requirements worldwide

Exposure to international submissions is preferred.

510K submission experience is a plus.

JOB FAMILY:

Regulatory Operations

DIVISION:

APOC Point of Care

LOCATION:

United States > Princeton : 400 College Road East

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

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

Abbott

is about the power of health. For more than 125 years, Abbott

has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott

come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott

, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott

welcomes and encourages diversity in our workforce.

Company info

Abbott
Website : http://www.abbott.com

Company Profile
We’re dedicated to fulfilling the promise of human potential, in all places, in all aspects and stages of life. We believe that health is the key to that promise. Because at our healthiest, we’re capable of achieving anything. And that’s why our pursuit of helping people achieve their best health at every life stage will never end. This is how we put that belief into practice each and every day.

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