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.
Individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources.
Individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources. Supports necessary regulatory activities for global product market entry and maintenance.
Maintains current registrations by preparing documentation required and submitting documentation on or in advance of schedule to achieve and or exceed departmental and organizational objectives. Maintain and enter regulatory submission data into database and file systems.
Review protocols and reports to support regulatory file
Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
May exercise authority within pre-established limits and approval.
Understanding and knowledge of Medical and regulatory terminology
Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents
Familiarity of regulatory agency structure (ex. FDA), processes and key personnel
Principles and requirements of applicable product laws; Submission/registration types and requirements (either FDA or international regulatory agencies)
Principles and requirements of promotion, advertising and labeling
Provides support for review and update of regulatory processes and procedures.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations
Partner with cross-functional team to support product release process
Support all company initiatives as identified by management in support of Quality Management System (QMS) and other regulatory requirements
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors.
Complies with US FDA and international regulations and regulatory requirements, company policy and operating procedures.
BA or BSc degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, psychology), math, engineering, or medical fields is preferred.
2+ years experience in a regulated industry (e.g., medical products, pharmaceuticals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, clinical affairs, operations, or related area.
Strong organizational and follow-up skills as well as attention to detail
Multitasks, prioritizes and meets deadlines in timely manner
Demonstrated ability to think analytically, strategically and critically
Review, analyze documentation and work on projects/problems of limited scope
Research and locate information on regulatory requirements and similar products
Exercises judgment within defined procedures and practices to determine appropriate action
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications
Apply business ethical standards
Ability to travel approximately 5%, including internationally