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 function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual will work with a cross functional teams to develop strategic plans and be responsible for tracking and communicating progress to stakeholders.
MAIN RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:
Strategic Planning:
- Develops and manages strategies and timelines for complex regulatory registration activities
- Integrates team strategies across multiple sites and divisions
- Develops tools and templates for reporting progress to team and stakeholders
- Effectively manages communications via multiple venues including visual and virtual project management tools, stakeholder reviews, team reviews
- Identifies program risks and coordinates team in identifying contingency plans
- Utilize technical regulatory skills to propose strategies on complex issues
- Determines registration requirements and interactions with Legal manufacturer /IVDD/IVDR registration requirements
- Determines UDI strategies for products to be aligned with registration requirements and classification
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related team
Premarket and on-market activities:
- Align with project teams on registration requirements /establishment registrations and interaction with specific US device listing and Unique Device Identifier requirements.
- Communicate registration/device listing processes to internal stakeholders
- Provide strategic input and guidance on regulatory registration requirements to development teams
- Manage and execute US device listing compliance activities and UDI publishing activities
- Manages FDA interactions for importation issues
Job specific responsibilities may include
Official correspondent for ADD for US device listing and establishment registration activities. SME for interactions with US Unique Device Identifier (UDI) regulatory issues and input into development and alignment with other country UDI requirements
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 and TPMs. 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 program management
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.
Forecasts project related 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.
QUALIFICATIONS
Bachelor’s degree 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 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.)
4-5 yearsâ 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. Note: Higher education may compensate for years of experience.
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