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 114,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The Opportunity
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
The function of a Regulatory Affairs Manager, Advertising & Promotion is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured, advertised or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Main Responsibilities
Develop and train personnel on new regulatory policies, processes and SOPs and train key personnel. Recruit, develop and manage regulatory professionals.Evaluate regulatory risks of division policies, processes, procedures.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 multicounty regulatory strategy and update strategy based upon regulatory changes.Assist in regulatory due diligence for potential and new acquisitions and partnerships.Utilize technical regulatory skills to propose strategies on complex issues.Determine submission and approval requirements.Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other 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.Communicate application progress to internal stakeholders.Monitor and submit applicable reports and ensure appropriate responses are submitted 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 submission approval.Manage and execute preapproval compliance activities Post market.Oversee processes involved with maintaining annual licenses, registrations, listings and 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.Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.Influence/Leadership: Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership by communicating and providing guidance towards achieving department objectives. Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff. · Exercises judgment independently.Planning/Organization: Creates immediate to long-range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals. · Forecasts future needs including human and material resources and capital expenditures. · Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.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.Experience and Qualifications
Bachelor's Degree required preferably in engineering, science or a closely related discipline is desired.Master's Degree preferred in a technical area or M.B.A. is preferred.4-5+ years of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired. Management/Leadership experience with direct reports preferredHave a broad knowledge of various technical regulatory alternatives and their potential impact on the business, in addition to exercising good and ethical judgment within policy and regulations. In-depth knowledge of business functions and cross group dependencies/relationships to define successful regulatory strategies.Prefer knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements, and precedents; Regulatory agency structure, processes, and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising, and labeling. Domestic and international regulatory guidelines, policies and regulations a plus. Must be able to successfully handle multiple and competing priorities. Think analytically with good problem-solving skills. Organize and track complex information. Perform risk assessment or analysis.Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.