The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Life. to the Fullest.
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential. 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.
Leading an active lifestyle is vitally important to the people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives. Due to growth, we are currently adding a Manager of Regulatory Affairs to our Atlanta, GA team.
MAKE AN IMPACT
As Manager of Regulatory Affairs, you will leverage your knowledge of scientific, regulatory and business issues to meet required legislation, enabling products to be developed, manufactured and distributed that can prolong life. This key leader has influence at the department, group and site levels and is the recognized expert and resource within the department and may be tasked to analyze broad scope implications of changing regulations and guidance. You will identify data requirements, obtain data and ensure information is presented effectively for the successful registration of products worldwide.
Your accountabilities and opportunities in this role:
Develop new regulatory policies, processes and SOPs and train key personnel.
Evaluate regulatory risks of division policies, processes, procedures.
Recruit, develop and manage team of regulatory professionals.
Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams.
Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes and assist in regulatory due diligence for potential and new acquisitions.
Propose strategies on complex issues. Determine submission and approval requirements.
Identify emerging issues and anticipate regulatory obstacles throughout the product lifecycle. Develop solutions in collaboration with members of regulatory and related teams. Monitor trade association positions for impact on company products.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
Monitor impact of changing regulations on submission strategies and update internal stakeholders.
Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and appropriate responses to regulatory authorities.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Negotiate and interact with regulatory authorities during the development and review process to ensure successful submission approval.
Manage preapproval compliance activities post-market. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations.
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions.
Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Report adverse events to regulatory agencies and internal stakeholders. Provide regulatory input for product recalls and recall communications.
Execute and manage technical and scientific regulatory activities independently as a decision-maker on regulatory issues, and assure that deadlines are met.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
Work with limited direction and exercise some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long-term perspective for desired results.
EXPERIENCE YOU’LL BRING
Bachelors Degree 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.
8-10 + years experience in a regulated industry (e.g., medical products, nutritionals).
Regulatory Knowledge including Regulatory history, guidelines, policies, standards, practices, requirements and precedents. Solid understanding of regulatory agency structure, processes and key personnel, principles and requirements of applicable product laws and submission/registration types and requirements. GxPs (GCPs, GLPs, GMPs) experience. Knowledge of principles and requirements of promotion, advertising and labeling.
Knowledge of international treaties and regional, national, local and territorial trade requirements, agreements and considerations.
Domestic and international regulatory guidelines, policies and regulations experience.
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Experience leading functional groups in the development of relevant data to complete regulatory submissions.
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
MS in a technical area or M.B.A. is preferred.
PhD in a technical area or law is helpful.
Class III medical device experience.
Certification, such as RAC from the Regulatory Affairs Professionals Society, is a plus.
Influence/Leadership: Interface cross-functionally and at all levels across the organization; provide technical leadership to business units; mentor junior employees; exercise judgment independently.
Planning/Organization: Immediate to long range planning; budget management; forecasting future needs including human and material resources and capital expenditures
Decision Making/Impact: Effective decision-making is critical to this important role.
Additional Salary Information: Salary dependent on education, skills and experience.
Internal Number: 30979964
At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare
through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a
medical need, and treat conditions to help you get back to doing what you love.
With headquarters in north suburban Chicago, we serve people in more than 160 countries with leading medical devices,
diagnostics, nutrition products and branded generic medicines. Our 109,000 colleagues are helping millions of people to
live better and healthier, every day around the world.