Veterans at Abbott
Abbott Regulatory Affairs Manager in St. Paul, Minnesota
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.
Join our team in the St. Paul, MN location! In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory submissions to the FDA and other worldwide regulatory agencies.
Acts as a regulatory representative on core product development teams developing and communicating regulatory strategy, requirements, and impact of regulations
Review and approve all design control documentation (i.e. protocols, reports, labeling, etc.) required to support regulatory submissions
Maintains positive and cooperative communications and collaboration with all levels of colleagues, customers, contractors, and vendors
Review and approve product and manufacturing changes through the engineering change order process to assure compliance with regulatory requirements
Acts as liaison between Abbott and the various appropriate regulatory agencies
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Provides mentoring and leadership to team members
Performs other related duties and responsibilities, on occasion, as assigned
Bachelors degree (or equivalent); 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 or CQM from ASQ.) At least 4 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
At least 8 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
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
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 email@example.com