- Entry level
- No Education
- Salary to negotiate
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 103,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:This position entails management of submissions to regulatory bodies, requiring working knowledge of products under review and of relevant regulations.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Manage the APOC International Regulatory team. Team is responsible for supporting affiliates and distributors in registering products by preparing and filing documentation as required for international regulatory registrations, responding to any questions, and achieving timely regulatory clearance/approval for marketing.
- Monitor regulatory intelligence and identify and communicate changes impacting APOC.
- Develop Regulatory team expertise in project management and product knowledge, and maintain staffing needs to support all current and near term international filings.
- Create optimized regulatory strategies for international registration to support business goals and approval to ensure most efficient approval times.
- Review design changes for International Regulatory.
- Assist in review of international product labeling and marketing materials.
- Assist in development of relevant regulatory SOPs and training staff as necessary
- Ensure conformance to local country and EU regulations.
- Assist with other regulatory matters as requested.
Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 5-7 years experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Bachelor’s degree in a life science field
- 8 years experience in the medical device industry, or equivalent
- 5 years experience in a regulatory capacity within the medical device industry. IVD experience is a plus
JOB FAMILY:Regulatory Operations
DIVISION:APOC Point of Care
LOCATION:United States Princeton : 400 College Road East
TRAVEL: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
About the company
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
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.