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 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
ABOUT EPHF
Leading an active lifestyle is important to the many 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.
WHAT YOU’LL DO
The Manager of Regulatory Affairs leverages a combination of scientific, regulatory and business knowledge to ensure that products that are developed, manufactured or distributed meet required legislation.
Additionally, this person 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.
They 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.
Develop and train on new regulatory policies, processes and SOPs. Evaluate regulatory risks of division policies, processes, procedures.
Recruit, develop and manage 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.
Assist in regulatory due diligence for potential and new acquisitions.
Utilize technical regulatory skills to propose strategies on complex issues.
Determine submission and approval requirements.
Identify emerging issues.
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.
Monitor applications under regulatory review.
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 Postmarket.
Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with product postmarketing 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.
Properly interpret and apply regulatory requirements.
Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.
Completed work is reviewed from a relatively long
– term perspective for desired results.
Individual is recognized as a discipline expert and resource in regulatory affairs.
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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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).
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Regulatory Knowledge of 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.
International treaties and regional, national, local and territorial trade requirements, agreements and considerations.
Domestic and international regulatory guidelines, policies and regulations.
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Experience leading functional groups in the development of relevant data to complete a regulatory submission.
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)
Class III medical device experience
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career.
We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your li