Abbott Laboratories

Senior Manager, Regulatory Affairs - Lingo (on-site)

United States > Alameda : 2601 Harbor Bay Parkway · Senior

Sponsorship not specified$131k-$261kDetected 12 days ago

FDA RegulatoryMedical DevicesCommunicationProblem SolvingRegulatory Affairs

About the role

The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation.
Join us and grow your career as you help Abbott shape the future of healthcare.
We are recruiting for a Senior Regulatory Affairs Manager to join our team on-site in Alameda, CA.

Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
May manage and coach a team of regulatory employees.
Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
Recruits, coaches and develops organizational talent.
Builds strategic partnerships to further departmental and organizational objectives.

Minimum 9 years related work experience.
In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation.

Submission / registration types and requirements
Experience working with Class III implantable devices.
Effective verbal and written communication with diverse audience and team.
Analytical thinking with good problem-solving skills.
Experience managing and leading a team.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Must be able to lead and manage multiple and competing priorities and manage programs.
Working knowledge of QSR, ISO, and EN standards.

Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our 115,000 colleagues serve people in more than 160 countries.

Develops, monitors and appropriately adjusts the annual budget for department(s).

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
Creates an entrepreneurial environment.
Keeps the organization's vision and values at the forefront of decision making and action.

Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).

This listing is sourced directly from Abbott Laboratories's careers page and normalized into a canonical job model.