Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
International Regulatory Affairs Specialist II
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
We are currently hiring an International Regulatory Affairs Specialist II to work on-site at our Plymouth, MN location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies (primarily China)regulatory registration, ensuring products and procedures comply withregulations. Additionally, will support necessary regulatory activities required for product market entry.
Review applicability of medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission database and file systems. Ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience
2-3 years' experience in a regulated industry (e.g., medical products, nutritional). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Experience with 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.
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is
$60,000.00 – $120,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
