ABBOTT LABORATORIES Manager, Regulatory Affairs Salary in the United States

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.

We are seeking an experienced Manager, Regulatory Affairs within Abbott’s Structural Heart Business Unit. This position is responsible for planning, creating and implementing solutions for regulatory approvals of the valve surgical products.

Impact this role will have on Abbott:

• Manages the Regulatory Affairs function for a significant business segment.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Develops global regulatory strategies (in conjunction with international regulatory team members) for new and modified medical devices.
• Provides regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible regulatory ramifications and mentoring junior regulatory staff.
• Collaborates with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs to support global product development and launch strategies.
• Provides technical guidance and training to RA staff:
  • during strategy formulation, submission preparation and development of labeling, marketing or promotional materials and in
  • training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.

• Prepares submissions for new devices and device or manufacturing changes.
• Prioritizes work in accordance with business impact
• Establishes regulatory processes where needed
• Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).
• Reviews protocols and reports to support regulatory compliance and submissions.
• Reviews device labeling and advertising materials for compliance with regulatory submissions and applicable regulations.
• Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
• Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Your experience(s), education and knowledge:

• Bachelor’s degree in physical/natural sciences, engineering, a related field, or equivalent.
• Minimum of 10 plus years of progressively more responsible regulatory submissions experience, including experience with medical devices.
• A demonstrated working knowledge of domestic and international regulations relative to the medical device industry is required.
• A demonstrated ability to analyze and evaluate technologically complex devices is also needed.
• Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.
• Must be skilled at delegation, follow-up, and team building as well as a history of being able to multi-task and meet multiple project schedules on time.
• Must be able to work cooperatively and productively with others.
• Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential; the ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and rules is also required.
• Demonstrated personal computer skills including spreadsheet skills, word processing, data base management and other relevant project management applications.
• Must be able to maintain regular and predictable attendance.

Your preferred qualifications and education:

• Class III Medical Device experience
• Transcatheter valve experience a plus
• An advanced credential in a relevant discipline/concentration.
• Professional certification or designation.