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.
As an individual contributor, the role of an Associate Director, Regulatory Affairs in Abbott’s corporate Global Strategic Regulatory department is to combine knowledge of scientific, regulatory and business issues to identify regulatory changes that may impact Abbott’s businesses and to work collaboratively with cross-functional teams to develop strategies for advocacy and implementation. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual will comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations, manage moderately complex regulatory projects impacting more than one Abbott business, and provide strategic guidance to senior management and functional organizational leadership.
The successful candidate will possess strong knowledge of FDA regulations and guidance documents pertaining to the regulation of medical devices and in vitro diagnostics and will be responsible for leveraging that expertise to support Abbott’s regulatory objectives in Abbott’s key markets globally.
Core job responsibilities include:
Monitor emerging issues and identify solutions.
Develop global regulatory strategies and modify based upon regulatory changes.
Participate in trade association activities, including evaluating association positions for potential impact to Abbott’s businesses or products.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with cross-functional and cross-divisional teams.
Lead company-wide regulatory initiatives and manage projects involving multiple businesses and functional stakeholders.
Identify opportunities to influence policy and engage in external influencing efforts.
Work with people from various disciplines and cultures.
Utilize technical regulatory skills to propose strategies on complex issues.
Review and approve advertising and promotional items developed by Global Marketing to ensure regulatory compliance.
Identify need for new regulatory policies, processes and SOPs and approve them.
Critical Success Factors
Influence/Leadership · Develops, communicates, and builds consensus for operating goals that are in alignment with Abbott’s strategic objectives. · Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. · Builds strong relationships with business partners and stakeholders and leverages relationships to tactfully influence and gain their support to drive desired outcomes. · Represents Abbott externally to trade associations and government bodies when engaging in regulatory and policy influencing efforts. · Leads project teams or initiatives involving multiple functions and Abbott businesses. · Exercises judgment independently.
Anticipation/Planning · Holistic, big picture thinker, who anticipates changes in law, regulation, policy, enforcement, and/or business objectives and adapts approach as necessary to manage risks effectively and ensure regulatory compliance. · Creates immediate to long-range plans to carry out objectives established by senior management. · Forecasts future departmental needs including human and material resources and capital expenditures.
Decision Making/Impact · Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.
Collaboration · Firm understanding of available regulatory and business resources and ability to integrate information from a number of sources to achieve business results, including breaking down boundaries to create alignment as necessary, in a complex, global, matrixed environment.
Bachelor's 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 beneficial but not required.
Certification is a plus (e.g., 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 function prefered but may consider experience in quality assurance, research and development/support, scientific affairs, government affairs, operations, or related area. Note: Higher education may compensate for years of experience.
Regulatory knowledge of:
Principles and requirements of advertising and promotion;
FDA regulations, guidance and policies (experience with international regulatory frameworks is a plus);Regulatory agency structure, processes and key personnel; and
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Must have ability to handle multiple projects in fast-paced environment and exercise sound judgment.
Must be able to independently handle moderately complex matters with minimal supervision and understand which issues to elevate to senior management and appropriate timing for doing so.
In addition to top-notch regulatory expertise, must have excellent interpersonal, strategic thinking, communication and organizational skills.
Internal Number: Req. #30924142
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 160 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.