Abbott Manager Regulatory Affairs in Princeton, New Jersey
At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
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.
Abbott Point of Care has a new opening for Manager, Regulatory Affairs. As an individual contributor on the team, the candidate will contribute to the success by providing support for the regulatory department ensuring efficient and compliant business processes in a medical device environment.
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.
Knowledge, Skills & Abilities:
Execute and manage technical and scientific regulatory activities.
Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
Effectively communicate, prepare and negotiate both internally and externally with various regulatory agencies.
Properly interpret and apply regulatory requirements.
Interfaces with a variety of management levels on significant matters, often requiring the coordination activity across organizational units.
May lead a cross-functional or cross-divisional project team.
Provides technical leadership to business units.
- Bachelor’s degree (or equivalent) in Science or Engineering.
Minimum 7 years’ relevant experience in a regulated industry.
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 labelling.
Domestic and international regulatory guidelines, policies and regulations (including Europe).
Builds partnerships and mutual respect with regulatory authorities (e.g.; FDA, Notified Body)
Working knowledge of IVD self test submission is a plus
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Drive gap analysis for new regulations.
APOC Point of Care
United States > Princeton : 400 College Road East
Yes, 20 % of the Time
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.
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