Abbott Regulatory Affairs Project Manager – Clinical Chemistry in Lake Forest, Illinois
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.
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 Project Manager 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 may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
• Develop new regulatory policies; processes and SOPs and train key personnel on them
• 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
• Assist in the development of multi country 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
• Monitor trade association positions for impact on company products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Recruit; develop and mentor regulatory professionals
• Assess the acceptability of quality; preclinical and clinical documentation for submission filing
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile; prepare; review and submit regulatory submission to authorities
• 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
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Manage and execute preapproval compliance activities
• 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
• 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
Supervisory / Management Responsibilities:
Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also, may mentor other department members.
Position Accountability / Scope:
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.
Bachelor’s degree OR an equivalent combination of education and work experience
6 years’ work experience
Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to work independently with no oversight.
Ability to identify and solve problems in a strategic manner.
Ability to manage complex projects.
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.
Bachelor’s degree in a technical discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical field)
Master’s in a technical area highly preferred; PhD or law degree is helpful
8 years regulatory experience
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Experience working in a broader enterprise/cross-division business unit model
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org